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# Oncologic Panel to Review Multiple Myeloma BLA
- URL: https://www.fdaweb.com/oncologic-panel-to-review-multiple-myeloma-bla/
- Published: 2025-06-13T12:00:00.000Z
- Updated: 2026-09-14T15:14:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159359

FDA has scheduled a 7/17 meeting of its Oncologic Drugs Advisory Committee to review and vote on a GSK BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior line of therapy; and in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide.

Blenrep was originally granted accelerated approval in 2020 for heavily pretreated multiple myeloma patients. In 2022, its approval was withdrawn after the DREAMM-3 trial, designed to confirm the drug’s benefit, did not demonstrate superiority over standard treatment. Despite the withdrawal, GSK has continued clinical development with Blenrep in combination therapies, and there is ongoing research into its potential use in earlier lines of treatment for multiple myeloma. 

GSK describes Blenrep as an antibody-drug conjugate comprising a humanized BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.