US 9249227

Medicare price rule could hit Keytruda and Opdivo subcutaneous launches

Medicare · cancer · 5 min

CMS is proposing a Medicare drug price rule that could shape the outlook for subcutaneous Keytruda and Opdivo. The products are expected to be eligible for selection in the 2027 negotiation round for IPAY 2029.

FDA approves belzutifan plus pembrolizumab for adjuvant RCC

FDA · renal cell carcinoma · 6 min

The FDA approved belzutifan plus pembrolizumab as adjuvant therapy for clear cell renal cell carcinoma at high risk of recurrence after nephrectomy. The catalyst is based on phase 3 LITESPARK-022 data and adds another regulatory milestone for belzutifan.

FDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC

FDA · adjuvant renal cell carcinoma · 6 min

The FDA granted priority review to supplemental applications for belzutifan plus pembrolizumab in adjuvant renal cell carcinoma. The move extends Merck’s renal cancer catalyst path after evidence showed improved disease-free survival versus pembrolizumab alone.

FDA approves Keytruda for adjuvant NSCLC treatment, expanding Merck’s lung cancer label

FDA · lung cancer · 6 min

The FDA approved pembrolizumab (Keytruda) for adjuvant treatment of stage IB, II, and IIIA non-small cell lung cancer after resection and platinum chemotherapy. For Merck and investors, the key readout is how this label expansion may shape lung cancer franchise momentum and future catalyst tracking.