FDA accepts Blenrep combo for review in relapsed or refractory MM

BY: Phillip McLeod

The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application for belantamab mafodotin (Blenrep) in combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for patients who have undergone at least one prior therapy for multiple myeloma (MM).

The FDA’s decision is based on data from the phase III DREAMM-7 and DREAMM-8 trials, which showed statistically significant improvements in progression-free survival compared with the standard of care, and the DREAMM-7 trial also demonstrated a significant benefit in overall survival, according to a press release from GSK, the manufacturer of Blenrep.

If approved, these combinations could redefine treatment options for multiple myeloma at or after first relapse, according to GSK.

The FDA has set a decision date of July 23, 2025.

“Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration,” Hesham Abdullah, the senior vice president of Global Head Oncology, R&D at GSK, said in the release.