The US Food and Drug Administration (FDA) extended the review timeline for the Biologics License Application for the belantamab mafodotin combinations investigated in the DREAMM-7 and DREAMM-8 trials. The triplet combinations were being evaluated in patients with relapsed or refractory multiple myeloma (MM) who have had at least one prior treatment.
GSK, the manufacturer of belantamab mafodotin, announced that the FDA had granted an extension of the Prescription Drug User Fee Action (PDUFA) date until October 23, 2025. The original date was first set for the end of July 2025.
The announcement of the PDUFA extension was made by GSK almost a week after the FDA ODAC vote recommended against the belantamab mafodotin combinations, reflecting the committee’s questions regarding dosing and safety and whether the trial clearly represented US patients.
“GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review,” the company said in its press release.
Data from the DREAMM-7 and DREAMM-8 phase 3 trials showed belantamab mafodotin combinations of belantamab mafodotin, bortezomib, and dexamethasone (BVd) and belantamab mafodotin, pomalidomide, and dexamethasone (BPd), respectively, outperformed standard triplet therapies in slowing disease progression. This and other additional data supported the Biologics License Application provided to the FDA, including “statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival versus a daratumumab-based triplet in DREAMM-7,” the company wrote in its press release.
The triplet combination BPd is currently approved in the United Kingdom, Japan, Canada, and Switzerland. BVd and BPD are both approved in the United Arab Emirates.
Sagar Lonial, MD, of the Winship Cancer Institute at Emory University, who was not an author on either study, discussed the journey of belantamab mafodotin in the DREAMM trials on a SOHO Insider podcast earlier in 2025.
