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GSK Cancer Therapy Candidate Accepted for FDA Review
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GSK Cancer Therapy Candidate Accepted for FDA Review
Nov 25, 2024 4:32 AM

07:03 AM EST, 11/25/2024 (MT Newswires) -- GSK (GSK) said Monday that the US Food and Drug Administration has accepted to review a Biologics License Application for its experimental combination therapy to treat multiple myeloma patients who have received at least one prior line of treatment.

The company said the application is based on a phase 3 study of blenrep in combinations with bortezomib plus dexamethasone, and pomalidomide plus dexamethasone that showed statistically significant and clinically meaningful improvements in progression-free survival in patients.

The FDA is expected to decide by July 23, 2025.

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