GSK announces extension of US Food and Drug Administration review period for Blenrep (Belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma

CAR-T Digest - August 2020

23 July 2025: GSK announces extension of US FDA review period for Blenrep (Belantamab mafodotin) in relapsed/refractory multiple myeloma

The FDA has extended the review period for GSK’s Biologics License Application for Blenrep (belantamab mafodotin-blmf) combinations in relapsed/refractory multiple myeloma, with a new PDUFA date set for 23 October 2025
The extension allows the FDA additional time to review recently submitted information supporting the application for patients who have received at least one prior line of therapy
The BLA is backed by Phase 3 DREAMM-7 and DREAMM-8 trials, showing statistically significant and clinically meaningful progression-free survival and overall survival benefits for Blenrep combinations versus standard triplet regimens
Blenrep combinations have shown a consistent safety and tolerability profile aligned with the known effects of the individual agents involved
The therapy is already approved in the UK, Japan, Canada, Switzerland (DREAMM-8 only), and UAE, with regulatory reviews ongoing in China (with breakthrough therapy designation), and other major markets