By Ben Glickman

Merck & Co., Pfizer and Astellas Pharma have received approval from the U.S. Food and Drug Administration for using Keytruda in combination with Padcev to treat a form of bladder cancer.

Merck announced the FDA approval late Friday. The decision was based on the results from a trial conducted in collaboration with Seagen, now owned by Pfizer, and Astellas.

The new approval is specifically for Keytruda, Merck's immunotherapy drug, and Padcev, Seagen and Astellas' antibody-drug conjugate, in treating adult patients with locally advanced or metastatic urothelial cancer.

Merck said the approval was nearly five months prior to the FDA's target date.

Merck said the trial showed a statistically significant improvement in its major efficacy endpoints of overall survival and progression-free survival when compared to platinum-based chemotherapy.

Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

December 15, 2023 17:38 ET (22:38 GMT)

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