Blenrep re-approved by FDA for relapsed/refractory multiple myeloma

The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s (LSE: GSK) Blenrep belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.

The FDA approved Blenrep despite the regulator’s own advisory committee voting against recommendation in July, finding that the risks of the drug outweighed its benefits.

Blenrep is expected to generate at least £3 billion ($4.0 billion) in sales in its peak year. But GSK’s re-entry into the lucrative market has not been smooth, with Blenrep withdrawn from sale in the USA in 2022 after a trial found it was no better than other treatments. The drug was also withdrawn from the European market, but won reapproval from the European Commission in late July.