FDA Approves Belzutifan-Lenvatinib Combo for Advanced Kidney Cancer
MRK sits 92% above its 52-week low of $77.58.
Summary
The FDA approved Merck's belzutifan in combination with lenvatinib for advanced renal cell carcinoma with a clear cell component. The approval is based on Phase 3 LITESPARK-011 data showing median PFS of 14.6 months vs 10.6 months for cabozantinib and ORR of 53% vs 40%. The recommended dosage is 20 mg lenvatinib plus 120 mg belzutifan once daily until disease progression or unacceptable toxicity. This expands Merck's oncology portfolio beyond Keytruda, adding a new combination therapy in a competitive kidney cancer market. The approval follows a series of positive regulatory developments for Merck this year, including Keytruda approvals and the LIPFENDRA launch. Belzutifan is already approved for von Hippel-Lindau disease-associated tumors, and this new indication broadens its commercial opportunity. The combination targets a significant patient population and could contribute meaningfully to Merck's oncology revenue. Watch for launch details and pricing in upcoming earnings calls.
Updated with a BusinessWire report · What changed
Updates
· BusinessWire — The approval is based on Phase 3 LITESPARK-011 data showing median PFS of 14.6 months vs 10.6 months for cabozantinib and ORR of 53% vs 40%.
At the time of this announcement, MRK was trading at $149.05 on NYSE in the Life Sciences sector, with a market capitalization of approximately $367.7B. The 52-week trading range was $77.58 to $156.92. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.