BRIEF—FDA plans AdCom to review GSK's Blenrep before market return

16 June 2025

The US Food and Drug Administration (FDA) announced a forthcoming public advisory committee meeting (AdCom) of the Oncologic Drugs Advisory Committee to review GSK’s marketing application for Blenrep (belantamab mafodotin.

Blenrep, an antibody-drug conjugate (ADC), was withdrawn from global markets in 2022 following disappointing results from a confirmatory trial, but after positive readouts from two pivotal Phase III trials, GSK has been working to bring the BCMA-targeted ADC back as a treatment for relapsed or refractory multiple myeloma.

The news that the FDA would be convening an AdCom on July 17 to discuss Blenrep was revealed in a federal register notice.

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