Latest news with #Abecma
Medical News Today
5 days ago
- Health
- Medical News Today
Abecma side effects and how to manage them
As with other drugs, Abecma can cause side effects, such as fever, fatigue, and muscle and bone pain. If side effects of Abecma become difficult to tolerate, talk with your doctor or (idecabtagene vicleucel) is a brand-name intravenous (IV) infusion that's prescribed for adults with multiple myeloma in certain you have problems with side effects from Abecma, talk with your doctor or pharmacist. They can discuss ways to manage side effects or other available treatment has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the 'Boxed warnings for Abecma' section.»Learn more about Abecma, including details about its common side effects of AbecmaAbecma can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects persist, bother you, or become severe, be sure to talk with your doctor or pharmacist. These are just a few of the more common side effects reported by people who took Abecma in clinical trials:fevernauseaheadachemusculoskeletal paindiarrheainfectionfatiguechillsdifficulty breathingcytokine release syndrome (CRS)For more information about some of these side effects, see the 'Managing side effects' section and the 'Boxed warnings for Abecma' side effects of AbecmaMild side effects can occur with Abecma use. This list may not include all possible mild side effects of the drug. To find out more, you can refer to Abecma's prescribing side effects that have been reported with Abecma include:fever and chillsnausea and vomitingheadachemusculoskeletal paindiarrheaconstipationmild upper respiratory infection, such as the common coldfatigueskin rashedema (swelling from fluid retention)These side effects may be temporary, lasting a few days to weeks. However, if the side effects continue, worsen, or become too difficult to tolerate, be sure to talk with your doctor or After the FDA approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect during or after treatment with Abecma and want to tell the FDA about it, visit MedWatch or call more information about some of these side effects, see the 'Managing side effects' side effects of AbecmaAbecma may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Abecma's prescribing you develop serious side effects during or after Abecma treatment, call your doctor right away. If the side effects seem life threatening or you think you're having a medical emergency, immediately call 911 or your local emergency side effects that have been reported include:severe infectionlow levels of immunoglobulins (antibodies)CRSneurologic toxicitieshemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)prolonged cytopenia (low blood cell levels)T-cell malignancies (cancers)For more information about some of these side effects, see the 'Boxed warnings for Abecma' reactionFor some people, Abecma can cause an allergic reaction, but it's not clear whether this side effect occurred in the drug's general, symptoms of allergic reaction can be mild or to manageFor mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you've had a serious allergic reaction to dimethyl sulfoxide (DMSO), your doctor may recommend treatment with a different medication instead. (Abecma contains DMSO.)Boxed warnings for AbecmaAbecma has boxed warnings. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be is a type of cancer immunotherapy called CAR T-cell therapy. These therapies, including Abecma, carry certain serious risks. If you have questions about the following warnings, you can ask your doctor to provide more may cause CRS, which occurs when the immune system suddenly releases a large number of cytokines into the bloodstream. Cytokines are special proteins that help your immune system work. But in large amounts, cytokines cause too much inflammation in your body. CRS can be mild to severe and even life was common in studies of Abecma, causing symptoms such as fever, low blood pressure, and a fast heart rate. Some participants developed more severe symptoms. Tell your doctor right away if you develop symptoms of CRS during or after your Abecma infusion. Due to the risk of this side effect, your healthcare team will monitor you closely during and after your Abecma infusion and treat CRS if it occurs. CRS is typically treated with medications that reduce inflammation, including tocilizumab (Actemra) and corticosteroids. Neurologic toxicitiesAbecma may cause neurologic toxicities, which are side effects of the drug that affect the brain and nerves. Common side effects seen in Abecma's studies include mild headache, dizziness, and tremor. In rare cases, Abecma may cause serious and life threatening neurologic toxicity, such as seizures and encephalopathy (brain damage).Due to the risk of this side effect, your care team will check for signs and symptoms of neurologic toxicity every day for at least 7 days following your Abecma infusion. Tell your doctor right away if you develop any brain- or nerve-related symptoms during or after your Abecma for neurological toxicities usually includes medications, such as antiseizure drugs, to treat or help prevent is a rare, potentially life threatening condition resulting from widespread inflammation throughout the and symptoms of HLH/MAS reported from Abecma use in studies include low blood pressure, low blood cell counts, hypoxia (low oxygen), and problems with multiple organs. HLH/MAS can be fatal without early recognition and care team will monitor you carefully and treat the condition if it occurs. Treatment varies depending on the specific symptoms and their severity. Doctors typically give medications that reduce inflammation and manage cytopeniaAbecma's treatment regimen, including chemotherapy, may cause long-lasting cytopenia (low blood cell counts). Depending on the cell type, low blood cell counts can cause anemia, an increased risk of infections, and have blood tests throughout treatment so your doctor can monitor your blood cell levels. If your counts become too low, they'll prescribe treatments to raise them, such as blood transfusions.T-cell malignanciesIt's possible to develop another type of blood cancer following Abecma treatment. (Abecma is used to treat multiple myeloma, which is a type of blood cancer.) Specifically, Abecma can cause T-cell malignancies (cancers), including acute myeloid leukemia. (T cells are a type of immune system cell.) T-cell malignancies were an uncommon side effect reported in studies of to this risk, you'll have regular follow-up visits with your doctor to monitor for cancers after your Abecma treatment ends. Your doctor will likely recommend lifelong monitoring. If you have questions about the monitoring process, talk with your doctor about what to side effectsAfter receiving Abecma, you may be able to take steps to make side effects easier to manage. If you have problems with side effects that do not go away or they become worse, talk with your doctor or pharmacist. They can discuss options for managing side effects or other available treatment painMusculoskeletal pain was a common side effect reported in studies of Abecma. People reported the following symptoms: joint pain and stiffnessneck or back painbone painmuscle pain, strain, and stiffnessnoncardiac chest pain (chest muscle pain not involving the heart)Steps you can take to manage symptoms of mild pain include:taking over-the-counter (OTC) pain relieversapplying warm or cold compresses to the affected areastrying alternative remedies, such as acupunctureIf you experience more significant or ongoing pain, consider talking with your doctor about treatment options, such as prescription pain relievers. DiarrheaFor some people, Abecma can cause diarrhea. This side effect was common in studies of Abecma. Most cases were mild, but some people developed more severe diarrhea. Steps you can take to manage mild diarrhea include:avoiding certain foods or drinks that may cause diarrheadrinking water with electrolytes to help prevent dehydrationtaking OTC antidiarrheal medication, such as loperamide (Imodium)If these steps don't help or your diarrhea is severe, talk with your doctor about other possible causes. For example, certain infections can also cause diarrhea, and Abecma treatment increases your risk of infection. Your doctor can help determine the cause of diarrhea and recommend suitable treatment options.»Read more: Is it normal for diarrhea to last for a week?InfectionAbecma treatment can raise your risk of infection. Mild to severe infections caused by bacteria, viruses, and other microbes were commonly reported in studies of Abecma. Examples include upper respiratory infections and pneumonia. Symptoms vary widely depending on the type of infection, but may include:fever or chillsbody acheswet or dry coughsore throatdifficulty breathingdigestive tract issues, such as vomiting or diarrheaYour doctor will monitor you for infection. If you experience symptoms of an infection or think you have one, tell your doctor. They can order certain tests to help identify the underlying cause and determine whether treatment is necessary. Steps you can take to manage your risk of infection and treat symptoms include:avoiding people who have an infectionwashing your hands with soap and water frequentlywearing a mask in public placestaking OTC medications or trying home remedies for specific symptoms, such as fever»Learn more: 8 ways to avoid colds and the for AbecmaTake note of the following important information to consider before receiving has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the 'Boxed warnings for Abecma' precautionsBefore Abecma treatment, discuss your health history with your doctor. Abecma may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:active infections or inflammatory disorderspast infection with any of these viruses: hepatitis B virus (HBV) or HCVHIVcytomegalovirusprevious allergic reaction to this or a similar drugpregnancybreastfeedingDisclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Medical News Today
03-07-2025
- Health
- Medical News Today
Abecma (idecabtagene vicleucel) and cost
The cost of Abecma can vary based on several factors, including your insurance coverage. Coupons and drug savings programs can also lower the price you'll pay for cost and savingsAs with all medications, the cost of Abecma can vary. Factors that may affect the price for Abecma you'll pay include:your treatment planyour insurance coveragethe pharmacy you usethe cost of the visit to your healthcare professional to receive Abecma infusionswhether Abecma has a savings program (see the 'Financial and insurance assistance' section)To find out what the cost of Abecma will be for you, talk with your doctor, pharmacist, or insurance provider. Abecma coupons and savingsTo save money on your Abecma prescription, explore these Optum Perks vs. generic or biosimilar drugsAbecma is a type of immunotherapy called chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapies are made using cells from your own immune system. It is a custom-made treatment. It isn't available in a biosimilar or generic is a brand-name cell therapy. Its active ingredient is idecabtagene vicleucel, which is made using cells from your body's immune system. »To learn more about how Abecma is made and given, see this in-depth ARE COSTS DIFFERENT FOR BIOLOGIC DRUGS VS. BIOSIMILAR DRUGS?Biologic drugs can be expensive because of the research needed to test their safety and effectiveness. The manufacturer of a biologic drug can sell it for up to 12 years. When the biologic drug's patent expires, multiple manufacturers can create biosimilar versions. This marketplace competition may lead to lower costs for biosimilars. Also, because biosimilars are very similar to biologic drugs, they don't require the same costly and insurance assistanceIf you need financial support to pay for Abecma, or if you need help understanding your insurance coverage, help is available. For example:A program called Cell Therapy 360 is available for Abecma. For more information and to find out whether you're eligible for support, call 888-805-4555 or visit the program websites provide details about drug assistance programs, ways to make the most of your insurance coverage, and links to savings cards and other services. Two such websites are: Medicine Assistance ToolNeedyMeds» Learn more about saving money on prescriptions with or without considerationsYou may want to consider the following information if you have insurance and receive authorization: If you have insurance, your insurance company may require prior authorization before it covers Abecma. This means the company and your doctor will discuss Abecma in regard to your treatment. The insurance company will then determine whether the medication is a drug requires prior authorization but you start treatment without the prior approval, you could pay the full cost of the medication. You can ask your insurance company whether Abecma requires prior of insurance coverage: Abecma is given by your doctor or another healthcare professional. If you have insurance, the price of your Abecma doses may be billed through your medical coverage instead of the prescription drug portion of your insurance plan. This depends on your specific insurance plan and where you receive your Abecma doses, such as at your doctor's office, an infusion clinic, or a you have questions about this process, contact your doctor or your insurance Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Medscape
30-06-2025
- Health
- Medscape
FDA Drops REMS Programs for Some CAR-Ts
Using chimeric antigen receptor (CAR) T-cell therapies for blood cancer should be less burdensome following labeling updates from the FDA. Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel (Carvykti; Janssen) and idecabtagene vicleucel (Abecma; BMS) — and one CD19-directed therapy for lymphoma, lisocabtagene maraleucel (Breyanzi; BMS). In a June 26 letter to Janssen explaining the move, the agency said that 'the established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing the risks of cytokine release syndrome (CRS) and neurologic toxicities across products in the class of BCMA- and CD19-directed autologous CAR T cell immunotherapies' means that REMS programs are no long necessary to ensure safe use. The agency further streamlined the labels of the two BMS therapies by reducing requirements to stay near a health facility after treatment from 4 to 2 weeks and by dropping driving restrictions after treatment from 8 to 2 weeks. In a press statement, BMS applauded the 'class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety.' The company also noted that recent studies have made it clear that the 'vast majority of serious adverse events' with CAR T-cell therapy occur within the first 2 weeks of infusion. 'Today's announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy,' said Sally Werner, RN, BSN, CEO of Cancer Support Community, in the press release. M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@
Time of India
28-06-2025
- Health
- Time of India
US FDA eliminates risk evaluation, mitigation strategies for CAR-T cancer therapies
Bengaluru: The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a safety program to protect patients from risky drugs, for currently approved CAR-T cell immunotherapies. REMS is required by the FDA to ensure a drug's benefits outweigh its risks by managing serious safety concerns. The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed warnings for cytokine release syndrome and neurological toxicities, and medication guides. The cancer therapies include Bristol-Myers Squibb's Breyanzi and its partnered therapy Abecma with 2seventy bio , Johnson & Johnson's unit Janssen and Legend Biotech's Carvykti, Novartis AG's Kymriah, and Gilead Sciences' unit Kite's Tecartus and Yescarta. Bristol-Myers Squibb and Gilead Sciences did not immediately respond to Reuters' requests for comment. These are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma, the health regulator said. CAR-T treatment generally involves extracting disease-fighting white blood cells known as T-cells from a patient, re-engineering them to attack cancer and infusing them back into the body. In January 2024, the FDA asked several drugmakers to add a serious warning on the label of their cancer therapies that use CAR-T technology after reports of T-cell malignancies and adverse events identified since approval. The FDA earlier said the risk of T-cell malignancies including leukemia and lymphoma applies to all therapies in the class and can lead to hospitalization and death.
Yahoo
28-06-2025
- Health
- Yahoo
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb's Cell Therapy Labels
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access Only about 2 in 10 eligible patients currently receive cell therapy treatment; today's announcement will reduce unnecessary barriers for patients and providers PRINCETON, N.J., June 27, 2025--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. Despite the transformative potential of cell therapy, only about 2 in 10 eligible patients receive it, due to the confluence of complex logistical and geographic barriers affecting patients and providers. BMS is committed to a long-term goal of expanding access to cell therapy and supports today's class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety. Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. These prolonged requirements posed burdens on healthcare delivery systems and for certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers. The changes include: Driving restrictions reduced from 8 weeks to 2 weeks post treatment Requirement to stay within proximity of a healthcare facility following infusion reduced from 4 weeks to 2 weeks "CAR T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. "Today's FDA-approved label updates reinforce BMS' continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy." The FDA has also approved removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies. This change is likely to help further accelerate cell therapy into the community center setting. Together, these label updates reflect the growing body of clinical and real-world evidence underpinning the favorable efficacy and safety profile of CAR T cell therapy. To date, more than 30,000 patients have been treated with a CAR T cell therapy, with recent studies, including an analysis BMS presented earlier this month at the ASCO Annual Meeting, showing that the vast majority of serious adverse events (CRS and NTs) occur within the first two weeks of infusion. Following this announcement, BMS will work closely with the more than 150 treatment centers currently approved to administer Breyanzi and Abecma to remove the REMS programs. In parallel, BMS is focused on rapidly expanding the geographic footprint of cell therapy, with a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family and work. "Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future," said Sally Werner, chief executive officer, Cancer Support Community. "Today's announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy." As BMS continues to bring cell therapy to more patients, we are committed to working across the healthcare ecosystem to implement these label updates and continue to design and implement measurable programs to increase uptake and equitable access to cell therapy. For a list of programs and services currently offered to support patients through their BMS cell therapy journey, visit Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease. Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential. The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here. Breyanzi U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Abecma U.S. FDA-Approved Indication ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Breyanzi U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Abecma U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Warnings and Precautions: Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes. Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 106 CAR-positive T cells. The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS. Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 106 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 106 CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS. Monitor patients at least daily for 7 days following ABECMA infusion for signs or symptoms of CRS. Continue to monitor patients for signs and symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA. In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%). At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma. Monitor patients at least daily for 7 days following ABECMA infusion for signs or symptoms of neurologic toxicities. Continue to monitor patients for signs or symptoms of neurologic toxicities for at least 2 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time. Advise patients to avoid driving for at least 2 weeks following infusion. Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia. In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved. In KarMMa, one patient treated in the 300 x 106 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines. Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA. Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines. Febrile neutropenia was observed in 38% (133/349) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 106 CAR-positive T cells and 300 to 460 x 106 CAR-positive T cells, respectively. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines. Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL. Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dL. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA. Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared to none in the standard regimens arm at the time of the safety update. The median time to onset of myeloid neoplasm from ide-cel infusion was 338 days (Range: 277 to 794 days). Three of these five patients have died following the development of myeloid neoplasm. One out of the five cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy. Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include pyrexia, CRS, hypogammaglobulinemia, infections – pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at or follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include whether Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel) for the indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news View source version on Contacts Bristol Myers Squibb Media Inquiries: media@ Investors: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
