GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has extended the review period for its Biologics License Application (BLA) for Blenrep (belantamab mafodotin-blmf) combinations.
Blenrep combinations are intended for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The new action date under the Prescription Drug User Fee Act is set for 23 October 2025.
The extension allows the FDA additional time to assess further information submitted in support of the application.
Belantamab mafodotin-blmf is an investigational antibody-drug conjugate, comprising a humanised BCMA monoclonal antibody linked to the cytotoxic agent auristatin F.
The drug linker technology is licensed from Seagen, while the monoclonal antibody is produced using POTELLIGENT Technology from BioWa, part of the Kyowa Kirin Group.
The Biologics License Application is supported by efficacy results from two Phase 3 studies, DREAMM-7 and DREAMM-8.
DREAMM-7, a multicentre, open-label, randomised trial, evaluated Blenrep combined with bortezomib and dexamethasone (BVd) versus daratumumab with bortezomib and dexamethasone (DVd).
The trial enrolled 494 participants and showed that BVd nearly tripled median progression-free survival (PFS) compared to DVd, with a 42% reduction in the risk of death.
DREAMM-8, also a multicenter, open-label, randomised trial, assessed Blenrep with pomalidomide and dexamethasone (BPd) against bortezomib and pomalidomide with dexamethasone (PVd).
With 302 participants, the trial showed a near-tripling of median PFS for BPd, although overall survival trends were not statistically significant at interim analysis.
Blenrep combinations are already approved in Canada, Japan, Switzerland, the UAE, and the UK.
Also, applications are under review in China and the European Union (EU), following results from the DREAMM-7 trial.
GSK is optimistic about the data supporting Blenrep combinations and anticipates ongoing discussions with the FDA as the review progresses.
