Latest news with #multiplemyeloma
CBC
17 hours ago
- Health
- CBC
At-risk Albertans mindful of summer plans as measles cases climb
As a measles outbreak grows in Alberta, some who are vulnerable are taking extra precautions as summer events kick into high gear. Carla Jacobson lives in Edmonton and has four children, including a one-year-old and a newborn baby. The one-year-old only has one dose of the measles vaccine while the baby will have to wait months before she can get her first shot. "It's a little scary for sure," Jacobson said. Measles cases have been steadily rising in Alberta since March. As of Friday, 1,407 cases had been reported across the province since the outbreak began. The high case count has Jacobson more mindful of what her family of six will do this summer. "I don't really need to go to the mall. We have plenty of stuff to be able to do outside, like we don't even have to go to a spray park," she said. She said she will likely abstain from festivals such as Taste of Edmonton and KDays, which attract thousands of people. It's a similar story for Barry Gibson of Stony Plain, west of Edmonton. Gibson was diagnosed with multiple myeloma, a blood cancer, in 2021. His treatment included a stem cell transplant that wiped out his immunity. While he was able to get other immunizations again, he is not able to get the measles vaccine because it is a live vaccine. "So besides being immunocompromised, which puts you in greater jeopardy, I have no immunization for that particular disease," Gibson said. "It makes me very nervous." Gibson was able to take July off from cancer treatments because of lab results and is visiting family in Manitoba. When he returns to Alberta, he plans to take more precautions. While his doctors suggested he mask up when there are large crowds, the Alberta man said he is not willing to take that risk and plans to avoid large gatherings and summertime events. "I won't be going to the Fringe or the Edmonton Folk Festival. I just can't imagine sitting on Gallagher Hill there with all those hundreds and thousands of people all around me," he said. Gibson said his son offered him a ticket to an Oilers playoff game, but he declined. "If I had a feeling, it's disappointment that our society right now — I blame a lot of it on social media — but our society right now seems to be willing to believe things that are not necessarily scientifically accurate," he said. Greater risks for vulnerable Albertans Dr. Stan Houston, an infectious disease specialist, said newborns and young children who are not vaccinated are particularly vulnerable to severe outcomes from measles. He said they are dependent on herd immunity. "Pregnant women and small kids are having to be or should be pretty darn careful where they're going out, particularly in southern Alberta where the rates of transmission are highest," Houston said. He said those vulnerable cannot fight the virus. "All those risks that you hear about, pneumonia, encephalitis and death, are substantially more common across a broad spectrum of the different degrees of immune suppression," he said. "You don't really wanna tell [someone] to just go to a cave and hide out. They could make sure that everybody [who] they share a space with in their household is immune. That would be one key thing." Houston said respiratory viruses transmit poorly outside. "Outdoor festivals would be the least risky places. Whereas going to a bar with low ceilings in the winter when everything's shut down, places like that would be much more infectious," he said. In a statement to CBC News, the provincial Ministry of Primary and Preventative Health Services said large events could potentially increase the risk of exposure to respiratory viruses, including measles. "We continue to recommend that anyone attending large gatherings ensure their immunizations are up to date, practice good hand hygiene, and stay home if feeling unwell. These are the same precautions we have consistently encouraged to help reduce the spread of measles," the statement reads, in part. It also states that immunization rates in Calgary and Edmonton are strong, adding that, as of Thursday, there have been no confirmed or probable cases linked to the Calgary Stampede grounds or Stampede-related events.
Medical News Today
a day 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.
Yahoo
2 days ago
- Business
- Yahoo
GSK's Blenrep faces setback as FDA cancer committee votes against approval
The US Food and Drug Administration's (FDA's) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK's Blenrep (belantamab mafodotin) just days before the drug's Prescription Drug User Fee Act (PDUFA) date. This marks a significant setback for the UK-based pharma company, which is aiming to regain approval of the therapy after it was pulled from the US market in 2022 due to concerns raised by late-stage trial data. Blenrep was approved under the FDA accelerated approval process in 2020 to treat multiple myeloma (MM). It is an antibody drug conjugate (ADC) that combines a humanised BCMA monoclonal antibody with the cytotoxic agent auristatin F, linked together by a non-cleavable linker. The ODAC committee had a 7–1 split against the combination of Blenrep plus pomalidomide and steroid dexamethasone and a 5-3 split against the combination of Blenrep with bortezomib and dexamethasone. GSK states it remains confident in the benefit/risk profile of Blenrep as a combination therapy and will continue to work closely with the FDA as they complete the review of the drug in patients with relapsed or refractory multiple myeloma (r/r MM). The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date. The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved. Data supporting the drug's approval comes from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) studies. In the studies, many patients experienced keratopathy and Visual Acuity (KVA) events. All grade KVAs occurred in 92% and 93% of patients in DREAMM-7 and DREAMM-8, respectively, while more serious grade 3-4 events were found in 77% and 78% of patients in the same two studies. Blenrep combinations are approved in r/r MM in the UK and Japan, as well as other markets, including Switzerland, based on the results of DREAMM-8. Applications for approval in the European Union (EU) and China are ongoing, based on the results of the DREAMM-7 study. "GSK's Blenrep faces setback as FDA cancer committee votes against approval" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. 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
Reuters
2 days ago
- Health
- Reuters
GSK's blood cancer drug fails to secure US FDA advisers' support
July 17 (Reuters) - The U.S. Food and Drug Administration's panel of independent advisers on Thursday recommended against GSK's (GSK.L), opens new tab blood cancer drug Blenrep, citing concerns about safety of the drug. GSK has sought approval to re-launch Blenrep in combination with other treatments for patients with relapsed or refractory multiple myeloma who had received at least one prior therapy. The drug was withdrawn from the U.S. market in 2022 after failing to show it was better than an existing treatment in a late-stage study. GSK's U.S.-listed shares fell nearly 6% after the panel voted 5-3 to say the benefits of Blenrep with bortezomib and dexamethasone at the proposed dosage did not outweigh its risks. The panel also voted 7-1 against Blenrep in combination with pomalidomide and dexamethasone. The company did not immediately respond to a request for comment. Bortezomib and pomalidomide are approved cancer therapies, while dexamethasone is a widely used generic steroid drug. The FDA is expected to make a formal approval decision next week and typically follows the advice of its expert advisers, but is not required to do so. UK's drug regulator had approved the Blenrep combination treatments in April. The FDA advisers' vote comes after the agency's staff reviewers raised concerns about Blenrep on Tuesday, especially incidents of ocular toxicity such as blurred vision, photophobia, and dry eye. Even when Blenrep was approved in the U.S., it carried a warning for eye-related side effects. During Thursday's panel discussion, members also raised concerns around its dosing regimen and lack of U.S. patient representation in the trials. "It is really disappointing to see the fact that we're still allowing drugs to gain approval with less than 5% US enrollment," said panelist Daniel Spratt, who is also associate chief scientific officer at University Hospitals Cleveland Medical Center. Blenrep is an antibody-drug conjugate, a type of drug that destroys tumor cells while sparing healthy ones. GSK's new application was based on results from two late-stage trials in which the combinations helped reduce the risk of death and delay cancer progression.
Health Line
5 days ago
- Health
- Health Line
Understanding the Types of Multiple Myeloma
Key takeaways The types of active multiple myeloma are categorized by the overproduced immunoglobulin, with IgG being the most common and IgE the rarest and most aggressive. Smoldering multiple myeloma is a precancerous condition without symptoms that can progress to active myeloma, requiring monitoring but not always immediate treatment. Multiple myeloma is a cancer of the plasma cells. Plasma cells are found in the bone marrow. They help your body produce immune system proteins, also known as immunoglobulins or antibodies, that target and destroy pathogens. Pathogens are disease-causing organisms. With multiple myeloma, plasma cells multiply too quickly. They overproduce an irregular protein called a monoclonal protein (M protein). Unlike a healthy immune system antibody, this protein cannot fight pathogens. Common symptoms of myeloma include bone pain, fatigue, and nausea, but not everyone experiences them. This article overviews multiple myeloma types and subtypes and their features. Smoldering vs. active multiple myeloma Smoldering multiple myeloma (SMM) is a precancerous condition that can develop into multiple myeloma over time. People with SMM don't have symptoms, so they're not likely to know they have it. Indeed, most cases are detected incidentally. For example, a doctor might notice increased protein levels during a routine blood or urine test and discover SMM upon further testing. If you have SMM, you may not require any treatment. A doctor might suggest regular monitoring to look for signs of your condition progressing to active myeloma. How often does smoldering multiple myeloma become active? Most cases of SMM eventually progress to active multiple myeloma. According to research cited in a 2022 article: SMM carries a 50% risk of progressing to myeloma within 5 years. SMM carries a 65% risk of progressing to myeloma within 10 years. About 25% of people with SMM never develop myeloma symptoms. Still, the risk can vary a lot from person to person. Higher M protein levels and bone marrow plasma cell percentages carry a higher risk of progression to myeloma within a few years. Types of active multiple myeloma In contrast to healthy plasma cells, myeloma cells only produce one type of immunoglobulin, resulting in a surplus of that type. Myeloma is categorized according to the type of immunoglobulin that's overproduced. There are five types: IgG myeloma: This is the most common type. In a 2020 study including 8,468 people with myeloma, about 57% had IgG. IgA myeloma: In the same study, IgA accounted for 20% of myeloma cases. According to 2020 research, IgA may have lower long-term survival rates than IgG. IgM myeloma: While similar to IgG and IgA, this type is much rarer, making up only 1% of myeloma cases. Overproduction of IgM usually develops into other disorders, like Waldenstrom macroglobulinemia. IgD myeloma: This rare type accounts for less than 2% of myeloma cases. It's more common in males and more likely to start at a younger age. It's typically more aggressive. IgE myeloma: Only 0.1% of myeloma cases are IgE, making it the rarest type. It's more aggressive than other types and has lower survival rates. Light-chain myeloma Light-chain myeloma is the third most common type of multiple myeloma after IgG and IgA. It makes up about 15% of myeloma cases, according to a 2018 review. The term 'light chain' refers to the structure of immunoglobulins, which have two larger heavy chains and two smaller light chains. In light-chain myeloma, myeloma cells produce incomplete immunoglobins that do not have heavy chains. They only have light chains, also known as Bence-Jones proteins. Nonsecretory myeloma Nonsecretory myeloma is a rare form of myeloma that accounts for around 3–5% of cases. It occurs when cancerous myeloma cells are present in the bone marrow but don't make or release any immunoglobulins. This type of myeloma is sometimes more challenging to detect since it doesn't cause elevated levels of immunoglobulins in urine or blood. Doctors may use bone marrow scans, such as CT scans or PET scans, to make a diagnosis. Related plasma chain disorders Myeloma is a type of plasma chain or plasma cell disorder. That means it affects plasma cells' ability to produce immunoglobulins or antibodies. Related plasma chain disorders include: MGUS Monoclonal gammopathy of undetermined significance (MGUS) is a relatively common condition in which M proteins are present in your blood without affecting your health. Different countries have reported MGUS rates ranging from 0.05–6.1%. It's more common among certain groups, such as older adults and Black people. MGUS doesn't usually cause symptoms. Only around 1% of people who have it go on to develop active myeloma each year. Doctors typically suggest monitoring MGUS with regular blood tests. Solitary plasmacytoma A plasmacytoma is a plasma cell tumor. Most plasma cell tumors, including myeloma tumors, grow in the bone marrow. Multiple myeloma causes many tumors in bone marrow all over the body. In contrast, solitary plasmacytoma only causes one tumor. Because solitary plasmacytoma is limited to a single area, it's easier to treat. Doctors can usually remove the tumor via radiation, surgery, or both. Extramedullary plasmacytoma Extramedullary plasmacytoma occurs when a single plasma cell tumor grows in soft tissue rather than bone. In a 2022 study, 62% of these tumors were in the head and neck area. As with solitary plasmacytoma, the cancer is localized to a single area, and treatment with radiation or surgery is usually effective. Light-chain amyloidosis Light-chain amyloidosis is when light-chain proteins produced by abnormal plasma cells accumulate throughout the body. These deposits, known as amyloid deposits, can lead to organ damage. This condition can occur independently of myeloma cancer. However, it can also be a complication of multiple myeloma. Waldenstrom macroglobulinemia Waldenstrom macroglobulinemia (WM) is a rare form of cancer that shares features in common with multiple myeloma. WM cells overproduce IgM, an M protein that's sometimes overproduced in myeloma. Despite this similarity, experts classify WM as a type of non-Hodgkin's lymphoma because it affects the lymphatic system. Hyperdiploid vs. hypodiploid myeloma Doctors sometimes classify multiple myeloma tumors according to the number of chromosomes found in tumor cells: Hyperdiploid myeloma tumors have 47–74 chromosomes. Hypodiploid myeloma tumors have 44 or fewer chromosomes. The authors of a 2021 case report cite research suggesting that hyperdiploid multiple myeloma is typically less aggressive than the hypodiploid type. Frequently asked questions What is the most common type of multiple myeloma? Accounting for more than 50% of all myelomas, IgG is the most common type of multiple myeloma. The next most common types are IgA and light-chain myeloma. What is the most aggressive type of multiple myeloma? According to a 2020 study, IgA and light-chain myeloma are associated with poorer overall survival than other common types. The median overall survival was 4.7 years after diagnosis for people with IgA myeloma and 4.8 years after diagnosis for people with light-chain myeloma. The Canadian Cancer Society reports that IgE is the most aggressive type of myeloma. However, it is extremely rare. What is the difference between kappa and lambda multiple myeloma? Kappa and lambda are two types of light chains. In multiple myeloma, one or the other may be overproduced. According to a 2017 study, myeloma with lambda light chains carries a poorer overall outlook. Takeaway Multiple myeloma is a cancer that causes uncontrolled plasma cell growth. The hallmark of myeloma is the presence of M proteins in blood or urine. The type of M protein overproduced determines the type of myeloma.
