Merck and Eisai Present New Data on Kidney Cancer Therapy
- Clinical Trial Results: The Phase 3 LITESPARK-011 trial demonstrated that the combination of WELIREG and LENVIMA significantly improved progression-free survival (PFS), with a median PFS of 14.8 months compared to 10.7 months for cabozantinib, reducing the risk of disease progression or death by 30% (HR=0.70).
- FDA Application Progress: Based on the LITESPARK-011 trial data, the U.S. FDA has accepted two supplemental New Drug Applications (sNDA) for WELIREG and LENVIMA, with a target action date of October 4, 2026, marking a significant milestone for the company in the kidney cancer treatment space.
- Patient Response Rate: In the trial, 52.6% of patients responded to the combination treatment of WELIREG and LENVIMA, highlighting the potential of this regimen for patients with advanced renal cell carcinoma and further solidifying Merck's leadership in oncology.
- Safety Analysis: While 71.6% of patients experienced grade 3 or higher adverse events during treatment with WELIREG and LENVIMA, the safety profile remains acceptable compared to cabozantinib, indicating promising clinical applicability for this combination.
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Merck & Co Inc: FDA Establishes PDUFA Deadline of June 19, 2026 for Welireg and Keytruda
Merck & Co. Announcement: Merck & Co. has set a new date of June 19, 2026, for the FDA's decision regarding the approval of its drug, Welireg.
Key Drug Focus: The drug Welireg is significant for its potential impact on treatment options, particularly in the context of key health conditions.
FDA Grants Priority Review for Combination of Welireg and Keytruda by Merck & Co Inc.
- Merck & Co. Update: Merck & Co. has received priority review from the FDA for its combination treatment involving Welireg and Keytruda.
- Regulatory Milestone: The FDA's acceptance of the priority review signifies a potential advancement in treatment options for patients.
Combination of KEYTRUDA® (PEMBROLIZUMAB) and WELIREG® (BELZUTIFAN) as Adjuvant Therapy Lowers Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Early-Stage Renal Cell Carcinoma Patients
Key Findings: The combination of Keytruda (pembrolizumab) and Welireg (belzutifan) has been shown to reduce the risk of disease recurrence or death by 28% compared to Keytruda alone in certain patients.
Target Patient Group: This treatment is particularly effective for patients with early-stage renal cell carcinoma (RCC).
MERCK & CO INC - FDA AGREES TO EVALUATE TWO ADDITIONAL NDAs FOR WELIREG IN COMBINATION WITH LENVIMA
FDA Review: The FDA has accepted a review of two supplemental applications from Merck & Co. for their product, Welireg.
Product Focus: The review pertains specifically to the use of Welireg in treating certain conditions, highlighting its potential benefits in the medical field.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA DEMONSTRATES NOTABLE ENHANCEMENT IN PROGRESSION-FREE SURVIVAL
- Significant Improvement: Merck & Co's Lenviima shows notable progress in free survival rates for patients.
- Clinical Advancements: The findings indicate a substantial enhancement in treatment outcomes for those undergoing therapy.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA LOWERS DISEASE PROGRESSION RISK BY 30%
Merck & Co. Announcement: Merck & Co. has reported that its drug, Lenviima, significantly reduces the risk of disease progression.
Efficacy Rate: The treatment is shown to lower the risk of disease progression by 30%, indicating a promising advancement in patient care.
Merck & Co Inc: FDA Establishes PDUFA Deadline of June 19, 2026 for Welireg and Keytruda
Merck & Co. Announcement: Merck & Co. has set a new date of June 19, 2026, for the FDA's decision regarding the approval of its drug, Welireg.
Key Drug Focus: The drug Welireg is significant for its potential impact on treatment options, particularly in the context of key health conditions.
FDA Grants Priority Review for Combination of Welireg and Keytruda by Merck & Co Inc.
- Merck & Co. Update: Merck & Co. has received priority review from the FDA for its combination treatment involving Welireg and Keytruda.
- Regulatory Milestone: The FDA's acceptance of the priority review signifies a potential advancement in treatment options for patients.
Combination of KEYTRUDA® (PEMBROLIZUMAB) and WELIREG® (BELZUTIFAN) as Adjuvant Therapy Lowers Risk of Disease Recurrence or Death by 28% Compared to KEYTRUDA Monotherapy in Certain Early-Stage Renal Cell Carcinoma Patients
Key Findings: The combination of Keytruda (pembrolizumab) and Welireg (belzutifan) has been shown to reduce the risk of disease recurrence or death by 28% compared to Keytruda alone in certain patients.
Target Patient Group: This treatment is particularly effective for patients with early-stage renal cell carcinoma (RCC).
MERCK & CO INC - FDA AGREES TO EVALUATE TWO ADDITIONAL NDAs FOR WELIREG IN COMBINATION WITH LENVIMA
FDA Review: The FDA has accepted a review of two supplemental applications from Merck & Co. for their product, Welireg.
Product Focus: The review pertains specifically to the use of Welireg in treating certain conditions, highlighting its potential benefits in the medical field.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA DEMONSTRATES NOTABLE ENHANCEMENT IN PROGRESSION-FREE SURVIVAL
- Significant Improvement: Merck & Co's Lenviima shows notable progress in free survival rates for patients.
- Clinical Advancements: The findings indicate a substantial enhancement in treatment outcomes for those undergoing therapy.
MERCK & CO INC - WELIREG COMBINED WITH LENVIMA LOWERS DISEASE PROGRESSION RISK BY 30%
Merck & Co. Announcement: Merck & Co. has reported that its drug, Lenviima, significantly reduces the risk of disease progression.
Efficacy Rate: The treatment is shown to lower the risk of disease progression by 30%, indicating a promising advancement in patient care.
