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PFE Pfizer Inc

24.87
-0.07 (-0.28%)
Pre Market
Last Updated: 12:52:27
Delayed by 15 minutes
Share Name Share Symbol Market Type
Pfizer Inc NYSE:PFE NYSE Common Stock
  Price Change % Change Share Price High Price Low Price Open Price Shares Traded Last Trade
  -0.07 -0.28% 24.87 123,297 12:52:27

Merck, Pfizer, Astellas Get FDA OK For Expanded Use Of Keytruda Plus Padcev

15/12/2023 10:53pm

Dow Jones News


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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)

Copyright (c) 2023 Dow Jones & Company, Inc.

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