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# FDA Extends Review of GSK Multiple Myeloma BLA
- URL: https://www.fdaweb.com/fda-extends-review-of-gsk-multiple-myeloma-bla/
- Published: 2025-07-23T12:00:00.000Z
- Updated: 2026-09-14T15:17:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159560

FDA has extended by three months its review of a GSK BLA for Blenrep (belantamab mafodotin) combinations for treating patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The new user fee review action target date is 10/23, which is intended to allow more time to review additional information provided by the company.

The review extension follows last week’s (7/17) Oncologic Drugs Advisory Committee meeting that voted against approving the BLA. Panel members voted five to three against the risk-benefit profile on the proposed dosage of Blenrep in combination with bortezomib (Velcade) and dexamethasone; and seven to one against the risk-benefit profile on the proposed dosage of Blenrep in combination with pomalidomide (Pomalyst) and dexamethasone.

Panel members seemed to agree with concerns raised in an FDA [briefing document](https://www.fda.gov/media/187578/download?ref=fdaweb.com) )that highlighted a persistent and troubling safety signal — ocular toxicity. Despite new data showing that belantamab mafodotin, when combined with standard therapies, significantly improved progression-free survival compared to comparator regimens, panelists were significantly concerned that large numbers of patients experienced Grade 3 or 4 eye-related adverse events, including keratopathy, vision changes, dry eyes, and photophobia.

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 In 2022, its approval was withdrawn after the DREAMM-3 trial, designed to confirm the drug’s benefit, did not demonstrate superiority over standard treatment.