Blenrep + BorDex combination accepted for review by US FDA

CAR-T Digest - August 2020

Weekly Digest - November 2024

25 Nov 2024: Blenrep + BorDex combination accepted for review by US FDA

The U.S. FDA has accepted GSK’s Biologics License Application (BLA) for the use of Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BorDex) or pomalidomide and dexamethasone (PomDex) to treat patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
The FDA has set the Prescription Drug User Fee Act (PDUFA) action date for this application as July 23, 2025
The BLA submission is supported by positive results from the DREAMM-7 and DREAMM-8 Phase 3 trials. Both trials showed significant improvements in mPFS for Blenrep combinations (36.6 vs 13.4 months for DREAMM-7, NR at 21.8 vs 12.7 months; HR: 0.52; p<0.001 for DREAMM-8) compared to standard-of-care triplet combinations in relapsed/refractory multiple myeloma
The DREAMM-7 trial also demonstrated a statistically significant overall survival (OS) benefit for the Blenrep combination with a 43% (HR: 0.57 [95% CI: 0.40-0.80], p-value=0.00049) reduction in the risk of death, which has not yet reached the interim criteria for statistical significance but marking an important secondary endpoint achievement, while DREAMM-8 showed a positive OS trend, with 83% vs 76% of patients alive at the end of one year
In addition to the U.S., Blenrep combinations have been accepted for review in multiple other markets in 2024, including the European Union, Japan, the UK, Canada, Switzerland, and China, where it received Breakthrough Therapy Designation for its combination with bortezomib and dexamethasone