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Oct 24, 2025 12:00 PM

FDA Approves GSK's Withdrawn Blood Cancer Drug Blenrep

On Friday, the U.S. Food and Drug Administration (FDA) approved GSK Plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy.

The Blenrep approval is supported by data from the pivotal DREAMM-7 phase 3 trial.

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are more than 180,000 new cases of multiple myeloma diagnosed globally each year.

In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory ...