This is all great news for patients with renal cell carcinoma -- as those who don't respond well to Keytruda® (pembrolizumab), are now FDA cleared to get Welireg® (belzutifan), even if not enrolled in a study. And Fiercepharma has, as ever, done an excellent job of laying out the context for the story:
. . .Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely.
With a second FDA nod on Thursday for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.
The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and who have also been treated with a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TK1). . . .
Once this franchise is generating more than $1.6 billion a year in revenue, as it will with the RCC approval, by the 2025 time frame -- it will be a material item, as to Merck's overall results. Now you know. Onward.
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