By Fineline Cube 
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations. The evaluation was for use in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The FDA will take the committee’s recommendation into account as it finalizes its review ahead of the July 23, 2025 PDUFA date. GSK maintains confidence in Blenrep’s benefit/risk profile and will continue working closely with the FDA during the review process.
Blenrep Overview
Blenrep is an antibody-drug conjugate (ADC) composed of a humanized BCMA monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. Blenrep combinations are approved for relapsed or refractory multiple myeloma in the UK, Japan, and other markets, including Switzerland. Applications are under review in major markets such as the European Union and China, supported by the results of the DREAMM-7 trial, which received Breakthrough Therapy Designation and priority review.
Clinical Trial Results
Both the DREAMM-7 and DREAMM-8 Phase 3 trials achieved their primary endpoint of progression-free survival (PFS). However, DREAMM-7 met the key secondary endpoint of overall survival (OS), while DREAMM-8 did not. Safety data indicated a relatively high incidence of grade 3-4 treatment-emergent adverse events (TEAEs), leading to dose adjustments or discontinuations in a number of patients. Ocular toxicity was also reported, which is a unique toxicity not observed with current multiple myeloma treatments.
ODAC Concerns
According to ODAC materials, the main efficacy concern was the lack of statistically significant improvement in OS in DREAMM-8 and limited enrollment diversity. Additionally, the committee highlighted ocular toxicity as a unique safety issue. The ODAC experts ultimately voted against approval by a margin of 5:3.-Fineline Info & Tech