Merck's Belzutifan Wins Priority Review Status In Type Of Kidney Cancer

The FDA has granted Priority Review designation to Merck & Co MRK Belzutifan, formerly known as PT2977.

• The drug candidate was considered the centerpiece in Merck’s 2019 over $1billion buyout of Peloton Therapeutics.
• Belzutifan’s application seeks approval for von Hippel-Lindau (VHL) disease-associated renal cell carcinoma that doesn’t require immediate surgery.
• Regulators have slotted the candidate in for a September 15 goal date.
• The experimental drug itself is an oral HIF-2α inhibitor.
• HIF, or hypoxia-inducing factor, is a protein that controls how the body responds and adapts to oxygen levels. In VHL patients, HIF-2α accumulation can lead to abnormal blood vessel growth and cell proliferation.
• The priority review comes based on the Phase 2 study in which Belzutifan showed a 36.1% confirmed overall response rate in the trial, with 22 of 61 patients achieving a complete response.
• Merck is further evaluating the compound in Phase 3 trials as a monotherapy and a combo regimen in previously treated patients, as well as in a combo in first-line patients for advanced clear cell renal cell carcinoma.
• Price Action: MRK shares are trading 0.30% higher at $76.45 in market trading hours on the last check Tuesday.