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Share Name Share Symbol Market Type Share ISIN Share Description
Gsk Plc LSE:GSK London Ordinary Share GB00BN7SWP63 ORD 31 1/4P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  12.20 0.85% 1,439.60 1,440.80 1,441.20 1,451.60 1,416.40 1,421.80 9,432,627 16:35:16
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Pharmaceuticals & Biotechnology 34,114.0 5,442.0 87.6 16.4 58,554

GSK To Withdraw Blenrep's US Marketing Authorization After FDA Request

22/11/2022 8:06am

Dow Jones News


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By Michael Susin

 

GSK PLC said Tuesday that it has started the withdrawal process of the U.S. marketing authorization for its Blenrep treatment, following the request of the country's Food and Drug Administration.

The pharmaceutical giant said the request comes after its Dreamm-3 Phase 3 study in patients with relapsed or refractory multiple myeloma didn't meet its primary endpoint of progression-free survival.

The company said patients treated with Blenrep therapy who have been already enrolled in the risk evaluation and mitigation strategy program will have the option to enroll in a compassionate use program to continue to access treatment.

"We respect the agency's approach to the accelerated approval regulations and associated process," Chief Medical Officer Sabine Luik said. "We will continue the DREAMM clinical trial program and work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma."

 

Write to Michael Susin at michael.susin@wsj.com

 

(END) Dow Jones Newswires

November 22, 2022 02:51 ET (07:51 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.

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