FDA Approves Merck's Drug Belzutifan For Type Of Advanced Kidney Cancer In Pretreated Cancer Patients
Portfolio Pulse from Vandana Singh
The FDA has approved Merck & Co Inc's (NYSE:MRK) drug Welireg (belzutifan) for advanced renal cell carcinoma (RCC) in patients previously treated with PD-1/PD-L1 inhibitors and VEGF-TKI. This marks the first new treatment class approved for advanced RCC since 2015. The approval is based on the LITESPARK-005 trial results, where Welireg showed superior progression-free survival (PFS) and objective response rate (ORR) compared to Novartis AG's (NYSE:NVS) Afinitor (everolimus). MRK shares rose 0.58% in premarket trading.
December 15, 2023 | 1:59 pm
News sentiment analysis
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NEGATIVE IMPACT
Novartis' Afinitor was outperformed by Merck's Welireg in a clinical trial, which may impact NVS's competitive position in the RCC treatment market.
The approval of a competing drug that has shown superior efficacy in clinical trials could negatively affect Novartis' market share and sales for Afinitor, potentially leading to a short-term negative impact on NVS stock.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 70
POSITIVE IMPACT
Merck's Welireg approved by FDA for advanced RCC, showing superior trial results over Novartis' Afinitor. MRK shares increased 0.58% premarket.
The FDA approval of Welireg is a significant milestone for Merck, likely to boost investor confidence and potentially increase sales. The positive trial results and the premarket share price uptick suggest a favorable short-term impact.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100