Merck, Pfizer, Astellas Get FDA OK For Expanded Use Of Keytruda Plus Padcev
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.-
5 Undervalued Stocks to Buy to Play a Little Defense
-
Markets Brief: AI Leaders Excel In Earnings Season So Far
-
What History Tells Us About the Fed’s Next Move
-
What’s Happening In the Markets This Week
-
Alphabet’s New Dividend: What Investors Need to Know
-
Going Into Earnings, Is Palantir Stock a Buy, a Sell, or Fairly Valued?
-
Going Into Earnings, Is Eli Lilly Stock a Buy, a Sell, or Fairly Valued?
-
What’s the Difference Between the CPI and PCE Indexes?
-
After Earnings, Is Tesla Stock a Buy, a Sell, or Fairly Valued?
-
After Earnings, Is GE Aerospace Stock a Buy, a Sell, or Fairly Valued?
-
3 Good Stocks to Buy with Your Tax Refund in 2024 (Or with Any Extra Money)
-
SoFi Earnings: Revenue Growth Slows on Lower Loan Growth and Higher Credit Costs
-
Tesla: Full Self-Driving Approval In China Supports Our View for Deliveries Growth In 2024
-
Philips Earnings: Firm Reaches $1.1 Billion Settlement Agreement
-
AbbVie Earnings: Next-Generation Immunology Drugs Help Offset Humira Biosimilar Pressure
-
Exxon Earnings: Ignore Earnings Shortfall as Long-Term Growth and Improvement on Track