GSK today announced the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Blenrep (belantamab mafodotin) in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy. The US FDA has assigned a Prescription Drug User Fee Act action date of 23 July 2025.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration. The evidence from DREAMM-7 and DREAMM-8 supporting our Blenrep combinations submission has been further strengthened by the statistically significant overall survival results from the DREAMM-7 trial. We look forward to working with the FDA on this review.”

The US application is based on results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care triplet combinations in relapsed or refractory multiple myeloma.

This is the sixth major regulatory filing acceptance this year for belantamab mafodotin combinations in the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In 2024, belantamab mafodotin combinations have been accepted for review in the European Union2, Japan3 (with priority review), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8). In China4, the National Medical Products Administration has granted Breakthrough Therapy Designation for belantamab mafodotin in combination with bortezomib and dexamethasone, as well as priority review for the regulatory application based on the results of DREAMM-7.