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
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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
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