FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted against approval of GSK's Blenrep (belantamab mafodotin) combination therapies for relapsed or refractory multiple myeloma due to concerns about safety, particularly high rates of ocular toxicity, and questions over overall benefit-risk profile at the proposed dosing regimens134.

The panel voted 5-3 against Blenrep in combination with bortezomib and dexamethasone, and 7-1 against its use with pomalidomide and dexamethasone3.

FDA reviewers and advisory committee members raised concerns about high rates of eye-related side effects (keratopathy and visual acuity events), dose modifications, and limited dose exploration in clinical trials, specifically the DREAMM-7 and DREAMM-8 studies234.

Blenrep previously received accelerated approval in 2020, but was withdrawn from the U.S. market in 2023 after failing to demonstrate improved progression-free survival in the confirmatory DREAMM-3 trial23.

As a result of the negative advisory vote, it is unlikely that the FDA will approve Blenrep combinations in the United States, dealing a major blow to GSK's efforts to reintroduce the drug in the key U.S. market1.

Sources:

1. https://www.nasdaq.com/articles/fda-advisory-panel-votes-against-approval-gsks-blenrep-combo

2. https://www.biospace.com/fda/gsks-blenrep-dreamms-turn-fitful-as-fda-questions-comeback-in-multiple-myeloma

3. https://www.pharmacytimes.com/view/fda-panel-rejects-belantamab-mafodotin-combinations-for-multiple-myeloma-citing-safety-concerns

4. https://www.fiercepharma.com/pharma/gsk-eyes-blenreps-us-return-fda-flags-eye-safety-concerns-ahead-advisory-committee-meeting