GSK: applies to FDA for multiple myeloma treatment

(CercleFinance.com) - GSK announces that the US Food & Drug Administration has agreed to review its Biologics License Application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) to treat relapsed or refractory multiple myeloma after at least one line of treatment.


This application is based on two Phase III clinical trials, which showed significant improvements in progression-free survival and other secondary endpoints.

Data will be presented at the ASH meeting in December 2024. The FDA decision is expected by 23 July 2025.


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