Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…

ByRidhi Rastogi4 days ago

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Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots: The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25 Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…

ByDipanshu DixitDecember 13, 2024

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

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