FDA Grants Priority Review to Merck, Pfizer Bladder Cancer Drug Combo
Summary
The FDA has granted priority review for the expanded approval of the Keytruda (Merck) and Padcev (Pfizer/Astellas) drug combination in certain patients with muscle-invasive bladder cancer. This designation shortens the review period, with a target action date of August 17, and signals the FDA's view that the combination has the potential to provide significant improvements in treating this hard-to-treat disease. If approved, this regimen could become the first and only perioperative treatment for these patients regardless of cisplatin eligibility, establishing a new standard of care and significantly expanding the market opportunity for both Merck and Pfizer/Astellas.
At the time of this announcement, MRK was trading at $118.52 on NYSE in the Life Sciences sector, with a market capitalization of approximately $294.4B. The 52-week trading range was $73.31 to $125.14. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Dow Jones Newswires.