Latest news with #VHL
Time of India
02-07-2025
- Business
- Time of India
Lodha Developers to deposit ₹520 crore as security in legal case against V Hotels
NEW DELHI: Lodha Developers Ltd has been directed to deposit Rs 520.80 crore as security in relation to an ongoing case in the Supreme Court against V Hotels Ltd, which the company acquired last year through an insolvency process. In a regulatory filing on Wednesday, Lodha Developers Ltd informed that this matter is related to proceedings initiated by the Enforcement Directorate (ED) against the erstwhile promoter of V Hotels Ltd (VHL) . This was in relation to a transaction of Rs 520.80 crore, allegedly routed through VHL before the start of the insolvency process. Lodha expects that the matter will be heard expeditiously in the apex court and the deposit will be released. In April last year, Lodha Developers Ltd announced the takeover of VHL through the Corporate Insolvency Resolution Process (CIRP) under the Insolvency and Bankruptcy Code 2016. In the filing, the company said it acquired VHL in 2024 and paid the consideration to various creditors based on the approved resolution plan. The approval of the resolution plan was also upheld by the Supreme Court vide its order dated September 29, 2024. "This intimation is related to proceedings initiated by the Enforcement Directorate against the erstwhile promoter of VHL - Kerkar family in relation to their transactions in Cox & Kings group to the tune of Rs 520.80 crore, allegedly routed through VHL before the commencement of CIRP," Lodha Developers said. The matter was heard by the Bombay High Court, and it was held that the proceedings cannot be continued against VHL since the issue relates to actions of the erstwhile promoters prior to the commencement of CIRP. "The appeal against this order was heard by the Supreme Court, and it has been decided that Lodha Developers will deposit a sum of Rs 520.80 crore as security since this is the maximum claim in the matter. Upon this deposit, there is no other claim on VHL's properties or other assets. We expect the matter to be expeditiously heard and the deposit to be released in due course," the filing said. In April last year, Lodha Developers had said VHL has real estate assets which can be developed for residential and allied uses. "Under the said resolution plan, the company will pay Rs 900 crore in tranches over a period of 270 days," the company had said. Lodha Developers, erstwhile Mactotech Developers Ltd, is one of the leading real estate firms in the country. It has a strong presence in the Mumbai Metropolitan Region (MMR) and Bengaluru markets.
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Business Standard
02-07-2025
- Business
- Business Standard
Lodha Developers to deposit ₹520 cr as security in case against VHL
Lodha Developers Ltd has been directed to deposit ₹520.80 crore as security in relation to an ongoing case in the Supreme Court against V Hotels Ltd, which the company acquired last year through an insolvency process. In a regulatory filing on Wednesday, Lodha Developers Ltd informed that this matter is related to proceedings initiated by the Enforcement Directorate (ED) against the erstwhile promoter of V Hotels Ltd (VHL). This was in relation to a transaction of ₹520.80 crore, allegedly routed through VHL before the start of the insolvency process. Lodha expects that the matter will be heard expeditiously in the apex court and the deposit will be released. In April last year, Lodha Developers Ltd announced the takeover of VHL through the Corporate Insolvency Resolution Process (CIRP) under the Insolvency and Bankruptcy Code 2016. In the filing, the company said it acquired VHL in 2024 and paid the consideration to various creditors based on the approved resolution plan. The approval of the resolution plan was also upheld by the Supreme Court vide its order dated September 29, 2024. "This intimation is related to proceedings initiated by the Enforcement Directorate against the erstwhile promoter of VHL - Kerkar family in relation to their transactions in Cox & Kings group to the tune of ₹520.80 crore, allegedly routed through VHL before the commencement of CIRP," Lodha Developers said. The matter was heard by the Bombay High Court, and it was held that the proceedings cannot be continued against VHL since the issue relates to actions of the erstwhile promoters prior to the commencement of CIRP. "The appeal against this order was heard by the Supreme Court, and it has been decided that Lodha Developers will deposit a sum of ₹520.80 crore as security since this is the maximum claim in the matter. Upon this deposit, there is no other claim on VHL's properties or other assets. We expect the matter to be expeditiously heard and the deposit to be released in due course," the filing said. In April last year, Lodha Developers had said VHL has real estate assets which can be developed for residential and allied uses. "Under the said resolution plan, the company will pay ₹900 crore in tranches over a period of 270 days," the company had said. Lodha Developers, erstwhile Mactotech Developers Ltd, is one of the leading real estate firms in the country. It has a strong presence in the Mumbai Metropolitan Region (MMR) and Bengaluru markets.
Newsweek
17-06-2025
- Health
- Newsweek
Teen Brushes Off Eye Discomfort—Years Later Comes Life-Changing Diagnosis
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. At age 16, Julia Máté noticed something wrong with her vision. But she could never have predicted the diagnosis, and huge decision, that would come decades later. "I noticed that I had a black curtain covering most of my vision in my left eye," Máté, who is from Hungary, told Newsweek. "They did a surgery called Cryotherapy, which is freezing of a bleeding blood vessel. And that was not successful and later the retina detached and they couldn't save it." Doctors at the time believed it was a random event. "The doctors just assumed they had a spontaneous random retinal detachment, which didn't really make sense," she recalled. Despite having no vision in her left eye, Máté moved on, and it wasn't until she was living in the U.K. aged 34 that she began experiencing new symptoms—this time in her right eye. "I noticed that when I looked at the right wall, I could see specks of grey on it," she said. Concerned that her vision was changing in her good eye, she went to the hospital. "That was my only eye," she said. What doctors told her next changed everything. "They said I had a lesion... I didn't even know what lesion meant... Lesion is cancer, you know, that's the worst thing you think of," she said. Then came the diagnosis: Von Hippel-Lindau (VHL) syndrome, a rare genetic condition that can cause tumors and cysts across the body. "They said we think you have a condition called Von Hippel Lindau syndrome and it can affect your kidneys as well. And I remember leaving the hospital thinking did they just say kidneys? Like it makes no sense... do I have an eye condition that affects my kidneys?" Máté recalled. A genetic test later confirmed the mutation. "They found a mutated VHL gene. Von Hippel Lindau syndrome is a genetic condition where your body has a mutation in a gene that stops tumors from growing," she said. "When that gene is mutated, it allows tumors to grow basically anywhere—in your brain, in your spine, in your kidneys, in your eyes." Pictures from some of Julia's videos where she has been sharing her experience with Von Hippel-Lindau syndrome (VHL). Pictures from some of Julia's videos where she has been sharing her experience with Von Hippel-Lindau syndrome (VHL). @julia_with_one_i/TikTok The rare genetic disorder occurs in around 1 in 50,000 births and results in a high quantity of malignant and benign tumors and cysts that appear throughout a patient's lifetime. Most commonly, tumors occur in the retina, brain, spinal chord and kidneys. It wasn't until seven years later that the condition led Máté, now 41, to an extraordinary decision: to electively remove her left eye, which had long been blind and had become increasingly painful. "I felt like I didn't have any other way to improve the look of it," she explained. "I had a cosmetic shell but my eye started to not tolerate it was horrendously painful." Without the shell, she resorted to wearing glasses with foil over one lens to try and improve the appearance of the eye, but earlier this month she underwent surgery to remove the eye completely. The huge decision resulted in an enucleation surgery, a medical term for the removal of the entire eyeball from the eye socket. This surgery leaves the surrounding eye muscles and orbital contents intact. After the eyeball is removed, a spherical implant is inserted into the socket to maintain its shape, and later, a prosthetic implant can be fitted restore a natural appearance. Though Máté expected relief, the emotional toll of the surgery caught her off guard. "I just thought I would feel relief, I didn't expect a more complex wave of emotion. I really did cry a lot and that was not something I really thought I would do," she said. "I chose this. So why am I feeling like this? I was confused, kind of conflicted. Do I have a right to feel sad if I made a choice?" As she continues to recover, Máté has made the extraordinary step to share her journey openly online, posting updates on her TikTok page. "I wanted to find someone who went through this [and] I couldn't find an account where someone documented the entire journey from day-to-day. So I wanted to educate people. Also, I want to raise awareness for VHL, because no one knows about it," she explained. The response has been overwhelming as people have shared messages of support and thanks for Máté's videos. "So many people send me messages and are interested in following. They watch every video and cheer me on, people can really be amazingly kind," she said. Máté is now looking ahead to August, when she'll be fitted for a prosthetic. "They basically put some stuff in there that hardens, and then they can create a prosthetic to match the exact shape and size. They paint basically an eyeball on it," she said.
News18
09-06-2025
- Health
- News18
Why Regular Kidney Cancer Screening After 40 Is a Must
Last Updated: In a world where preventive health is gaining increasing importance, incorporating regular kidney check-ups alongside heart and liver assessments can offer holistic protection Kidney cancer, often dubbed the 'silent killer" of the urogenital tract, is steadily becoming a significant concern among individuals over the age of 40. With a high mortality rate and subtle early symptoms, this disease often goes undetected until it has progressed to an advanced stage. Experts now emphasize that regular screening post-40 can be a lifesaving intervention—especially for high-risk groups. A Growing Concern After 40 According to Dr Kavitha Vijayakumar, AVP & Lab Operations, Metropolis Healthcare Ltd (Tamil Nadu, Andhra Pradesh & Telangana), 'Kidney cancer most commonly occurs after 40 years of age, with a higher frequency in men compared to women. The risk is compounded by lifestyle factors like smoking, alcohol consumption, and hypertension." What makes kidney cancer particularly dangerous is its ability to remain asymptomatic. 'Sixty percent of patients with kidney cancer are indeed asymptomatic, which explains why early diagnosis is so rare. A quarter of them are already in the metastatic stage when diagnosed," she adds. Symptoms, when they do occur, are often vague such as easy fatigue or low back pain which can be easily misattributed to other common conditions. Why Screening Is Crucial 'While cardiac screenings and cholesterol checks have become commonplace after 40, kidney cancer screening is often overlooked despite its severity," notes Dr. Kavitha. She recommends a simple ultrasound, which can be highly sensitive in detecting kidney tumors, especially depending on the size and location of the lesion. These non-invasive screenings can help flag abnormalities before symptoms set in, offering a critical window for early intervention. Dr. Samir Khanna, Director, Urology, CK Birla Hospital, Delhi, echoes these concerns and provides a broader view of the evolving landscape. 'Kidney cancer is most frequently diagnosed between the ages of 50 and 70, but there's a noticeable rise in incidence starting as early as 40. Age is a well-established risk factor—along with smoking, hypertension, obesity, and prolonged exposure to toxins," he explains. Certain populations, especially long-term dialysis patients and those with a family history of kidney cancer or genetic disorders like Von Hippel-Lindau (VHL) syndrome, are particularly vulnerable. 'Fortunately," Dr. Khanna adds, 'screening doesn't need to be complicated. Non-invasive tools like routine urine tests and ultrasounds can help detect tumors incidentally in their early stages—often when the cancer is still manageable through minimally invasive treatments like partial nephrectomy or ablation." Advanced Tools & Technologies In recent years, there's been a significant shift toward innovative screening methods. 'Emerging technologies like liquid biopsies and circulating tumor DNA tests are showing promise in detecting tumors at a molecular level," says Dr. Khanna. 'Artificial intelligence is also being integrated into imaging to better differentiate between benign and malignant kidney masses." These advancements could soon revolutionize early detection, making screening even more precise and accessible. Both experts stress that kidney cancer screening after 40 should not be a luxury—it's a preventive essential, particularly for those with risk factors. As Dr. Kavitha rightly points out, 'Detecting kidney cancer early can mean the difference between a simple outpatient treatment and complex, life-altering surgery." In a world where preventive health is gaining increasing importance, incorporating regular kidney check-ups alongside heart and liver assessments can offer holistic protection. If you're over 40, especially with a personal or family history of the disease, speak to your healthcare provider about getting screened.
Yahoo
18-02-2025
- Health
- Yahoo
WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications
WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union RAHWAY, N.J., February 18, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has conditionally approved WELIREG® (belzutifan), Merck's oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for: The treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable; The treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies. The EC approval of these two indications is based on results from the LITESPARK-004 and LITESPARK-005 trials, respectively, and follows the positive recommendation from the Committee for Medicinal Products for Human Use adopted in December 2024. This marks the first approval for WELIREG in the European Union (EU). WELIREG is now approved in over 30 countries for certain adult patients with previously treated advanced RCC and in more than 40 countries for adult patients with certain eligible VHL disease-associated tumors. "The approval of WELIREG in the EU introduces the first and only systemic treatment option for adult patients with certain VHL disease-associated tumors for whom localized procedures are unsuitable, and offers a new option for adult patients with advanced clear cell renal cell carcinoma that progressed following a PD-1 or PD-L1 inhibitor and at least two VEGF targeted therapies," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "This is an important moment, and we are pleased that WELIREG, a first-in-class HIF-2α inhibitor, can now potentially help these patients in need." This approval allows marketing of WELIREG for these indications in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. The conditional approval of WELIREG will be valid for one year, subject to yearly renewal, pending additional clinical data from LITESPARK-004 and another ongoing Phase 2 trial of WELIREG in patients with certain VHL disease-associated tumors. Timing for commercial availability of WELIREG in individual EU countries will depend on multiple factors, including the completion of national reimbursement procedures. Results in Patients With Certain Eligible VHL Disease-associated Tumors (LITESPARK-004) WELIREG is now the first and only systemic therapy for the treatment of VHL disease-associated tumors in the EU. The approval in adult patients with certain eligible VHL disease-associated tumors is based on objective response rate (ORR) and duration of response (DOR) results from the LITESPARK-004 trial. WELIREG was approved in the U.S. in August 2021 for the treatment of adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas or pNET not requiring immediate surgery based on the results from LITESPARK-004. In patients with VHL disease-associated RCC (n=61), WELIREG showed an ORR of 49% (95% CI, 36-62) (n=30/61); all responses were partial responses (PR). Median DOR for these patients was not reached, with ongoing responses ranging from 2.8+ to 22+ months; among responders, 56% (n=17/30) maintained a response for at least 12 months. Among these 61 patients, the study also evaluated response rates in other common disease-associated tumors including CNS hemangioblastomas and pNET. In patients with VHL disease-associated CNS hemangioblastomas (n=24) in this trial, WELIREG showed an ORR of 63% (95% CI, 41-81) (n=15/24), with a complete response (CR) rate of 4% (n=1/24) and a PR rate of 58% (n=14/24). Median DOR for these patients was not reached, with ongoing responses ranging from 3.7+ to 22+ months; among responders, 73% (n=11/15) maintained a response for at least 12 months. In patients with VHL disease-associated pNET (n=12) in this trial, WELIREG showed an ORR of 83% (95% CI, 52-98) (n=10/12), with a CR rate of 17% (n=2/12) and a PR rate of 67% (n=8/12). Median DOR for these patients was not reached, with ongoing responses ranging from 11+ to 19+ months; among responders, 50% (n=5/10) maintained a response for at least 12 months. Results in Certain Patients With Previously Treated Advanced RCC (LITESPARK-005) The approval in adult patients with advanced clear cell RCC that progressed following two or more lines of therapy, including a PD-1 or PD-L1 inhibitor and at least two VEGF targeted therapies, is based on progression-free survival (PFS) and ORR results from the LITESPARK-005 trial, which was the first trial in advanced RCC to specifically evaluate patients who progressed following these treatments. WELIREG was approved in the U.S. in December 2023 for the treatment of adult patients with advanced RCC following both a PD-1 or PD-L1 inhibitor and a VEGF-tyrosine kinase inhibitor based on the results from LITESPARK-005. In the trial, WELIREG reduced the risk of disease progression or death by 25% (HR=0.75 [95% CI, 0.63-0.90]; p=0.0008) versus everolimus. Median PFS was 5.6 months (95% CI, 3.9-7.0) for WELIREG versus 5.6 months (95% CI, 4.8-5.8) for everolimus. The ORR for WELIREG was 22% (n=82) (95% CI, 18-27), with a CR rate of 3% (n=10) and a PR rate of 19% (n=72), and the ORR for everolimus was 4% (n=13) (95% CI, 2-6), with no patients achieving a CR and a PR rate of 4% (n=13). About LITESPARK-004 LITESPARK-004 is an open-label Phase 2 trial ( NCT03401788) evaluating WELIREG for the treatment of patients with VHL disease who had at least one measurable solid tumor localized to the kidney and who did not require immediate surgery. The study enrolled 61 patients who received WELIREG (120 mg orally once daily) until disease progression or unacceptable toxicity. The primary endpoint is ORR in VHL disease-associated RCC. Secondary endpoints include, DOR, time to response, PFS, time to surgery and safety. Additionally, this study evaluated response rates in other common VHL disease-associated tumors including pNET and CNS hemangioblastomas. About LITESPARK-005 LITESPARK-005 is an open-label, randomized, active-controlled Phase 3 trial ( NCT04195750) evaluating WELIREG compared to everolimus for the treatment of patients with unresectable, locally advanced or metastatic clear cell RCC that progressed following PD-1 or PD-L1 checkpoint inhibitor and VEGF receptor targeted therapies either in sequence or in combination. The trial enrolled 746 patients who were randomized to receive WELIREG (120 mg orally once daily) or everolimus (10 mg orally once daily). The dual primary endpoints are PFS and overall survival. Secondary endpoints include ORR, DOR and safety. About von Hippel-Lindau disease Von Hippel-Lindau disease is a rare genetic disease, which impacts an estimated 200,000 people worldwide and an estimated 10,000 to 15,000 people in Europe. Patients with VHL disease are at risk for recurrent, benign blood vessel tumors as well as some cancerous ones. One of the most commonly occurring tumors is RCC, a form of kidney cancer, which occurs in about 70% of patients with VHL disease. About renal cell carcinoma Renal cell carcinoma is by far the most common type of kidney cancer. Clear cell RCC is considered the most common form of RCC, representing about 70% of all cases. In 2020, more than 130,000 new cases of RCC were diagnosed in Europe. Renal cell carcinoma is about twice as common in men than in women. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage. About WELIREG® (belzutifan) 40 mg tablets, for oral use Indications in the U.S. Certain von Hippel-Lindau (VHL) disease-associated tumors WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Advanced Renal Cell Carcinoma (RCC) WELIREG is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). Selected Safety Information for WELIREG Warning: Embryo-Fetal Toxicity Exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception as WELIREG can render some hormonal contraceptives ineffective. Anemia WELIREG can cause severe anemia that can require blood transfusion. Monitor for anemia before initiation of, and periodically throughout, treatment. Transfuse patients as clinically indicated. For patients with hemoglobin <8 g/dL, withhold WELIREG until ≥8 g/dL, then resume at the same or reduced dose or permanently discontinue WELIREG, depending on the severity of anemia. For life-threatening anemia or when urgent intervention is indicated, withhold WELIREG until hemoglobin ≥8 g/dL, then resume at a reduced dose or permanently discontinue WELIREG. In LITESPARK-004 (N=61), decreased hemoglobin occurred in 93% of patients with VHL disease and 7% had Grade 3 events. Median time to onset of anemia was 31 days (range: 1 day to 8.4 months). The safety of erythropoiesis-stimulating agents (ESAs) for treatment of anemia in patients with VHL disease treated with WELIREG has not been established. In LITESPARK-005 (n=372), decreased hemoglobin occurred in 88% of patients with advanced RCC and 29% had Grade 3 events. Median time to onset of anemia was 29 days (range: 1 day to 16.6 months). Of the patients with anemia, 22% received transfusions only, 20% received ESAs only, and 12% received both transfusion and ESAs. Hypoxia WELIREG can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization. Monitor oxygen saturation before initiation of, and periodically throughout, treatment. For decreased oxygen saturation with exercise (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), consider withholding WELIREG until pulse oximetry with exercise is greater than 88%, then resume at the same or a reduced dose. For decreased oxygen saturation at rest (e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg) or when urgent intervention is indicated, withhold WELIREG until resolved and resume at a reduced dose or discontinue. For life-threatening or recurrent symptomatic hypoxia, permanently discontinue WELIREG. Advise patients to report signs and symptoms of hypoxia immediately to a healthcare provider. In LITESPARK-004, hypoxia occurred in 1.6% of patients. In LITESPARK-005, hypoxia occurred in 15% of patients and 10% had Grade 3 events. Of the patients with hypoxia, 69% were treated with oxygen therapy. Median time to onset of hypoxia was 30.5 days (range: 1 day to 21.1 months). Embryo-Fetal Toxicity Based on findings in animals, WELIREG can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. WELIREG can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose. Adverse Reactions In LITESPARK-004, serious adverse reactions occurred in 15% of patients, including anemia, hypoxia, anaphylaxis reaction, retinal detachment, and central retinal vein occlusion (1 patient each). WELIREG was permanently discontinued due to adverse reactions in 3.3% of patients for dizziness and opioid overdose (1.6% each). Dosage interruptions due to an adverse reaction occurred in 39% of patients. Those which required dosage interruption in >2% of patients were fatigue, decreased hemoglobin, anemia, nausea, abdominal pain, headache, and influenza-like illness. Dose reductions due to an adverse reaction occurred in 13% of patients. The most frequently reported adverse reaction which required dose reduction was fatigue (7%). The most common adverse reactions (≥25%), including laboratory abnormalities, that occurred in patients who received WELIREG were decreased hemoglobin (93%), fatigue (64%), increased creatinine (64%), headache (39%), dizziness (38%), increased glucose (34%), and nausea (31%). In LITESPARK-005, serious adverse reactions occurred in 38% of patients. The most frequently reported serious adverse reactions were hypoxia (7%), anemia (5%), pneumonia (3.5%), hemorrhage (3%), and pleural effusion (2.2%). Fatal adverse reactions occurred in 3.2% of patients who received WELIREG, including sepsis (0.5%) and hemorrhage (0.5%). WELIREG was permanently discontinued due to adverse reactions in 6% of patients. Adverse reactions which resulted in permanent discontinuation (≥0.5%) were hypoxia (1.1%) and hemorrhage (0.5%). Dosage interruptions due to an adverse reaction occurred in 39% of patients. Of the patients who received WELIREG, 28% were 65 to 74 years, and 10% were 75 years and over. Dose interruptions occurred in 48% of patients ≥65 years of age and in 34% of younger patients. Adverse reactions which required dosage interruption in ≥2% of patients were anemia (8%), hypoxia (5%), COVID-19 (4.3%), fatigue (3.2%), and hemorrhage (2.2%). Dose reductions due to an adverse reaction occurred in 13% of patients. Dose reductions occurred in 18% of patients ≥65 years of age and in 10% of younger patients. The most frequently reported adverse reactions which required dose reduction (≥1.0%) were hypoxia (5%) and anemia (3.2%). The most common (≥25%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (88%), fatigue (43%), musculoskeletal pain (33%), increased creatinine (34%), decreased lymphocytes (34%), increased alanine aminotransferase (32%), decreased sodium (31%), increased potassium (29%), and increased aspartate aminotransferase (27%). Drug Interactions Coadministration of WELIREG with inhibitors of UGT2B17 or CYP2C19 increases plasma exposure of belzutifan, which may increase the incidence and severity of adverse reactions. Monitor for anemia and hypoxia and reduce the dosage of WELIREG as recommended. Coadministration of WELIREG with CYP3A4 substrates decreases concentrations of CYP3A4 substrates, which may reduce the efficacy of these substrates or lead to therapeutic failures. Avoid coadministration with sensitive CYP3A4 substrates. If coadministration cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information. Coadministration of WELIREG with hormonal contraceptives may lead to contraceptive failure or an increase in breakthrough bleeding. Lactation Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with WELIREG and for 1 week after the last dose. Females and Males of Reproductive Potential WELIREG can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating treatment with WELIREG. Use of WELIREG may reduce the efficacy of hormonal contraceptives. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with WELIREG and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with WELIREG and for 1 week after the last dose. Based on findings in animals, WELIREG may impair fertility in males and females of reproductive potential and the reversibility of this effect is unknown. Pediatric Use Safety and effectiveness of WELIREG in pediatric patients under 18 years of age have not been established. Merck's focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovation products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Please see Prescribing Information, including information for the Boxed Warning about embryo-fetal toxicity, for WELIREG (belzutifan) at and Medication Guide for WELIREG at View source version on Contacts Media Contacts:Julie Cunningham, (617) 519-6264Michael McArdle, (908) 447-9453 Investor Contacts:Peter Dannenbaum, (732) 594-1579Steven Graziano, (732) 594-1583
