GSK To Withdraw Blenrep's US Marketing Authorization After FDA Request
22 November 2022 - 7:06PM
Dow Jones News
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)
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