The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.
GSK announced on July 23, 2025 that FDA has extended the company’s biologics license application (BLA) for belantamab mafodotin-blmf (Blenrep) for the treatment of relapsed/refractory multiple myeloma in patients who have received at least one prior type of therapy. The new Prescription Drug User Fee Act (PDUFA) action date, Oct. 23, 2025, will provide the agency additional time to review information provided to support the application.
Efficacy results from the DREAMM-7 and DREAMM-8 Phase III trials in relapsed or refractory multiple myeloma support the BLA with progression-free survival (PFS) rates for Blenrep combinations compared to triplet standard of care combinations and overall survival (OS) compared with a daratumumab-based triplet in DREAMM-7, according to GSK (1).
DREAMM-7 is a multicenter, open-label randomized Phase III clinical trialevaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in those patients who have been previously treated with a prior line of treatment. There were 494 trial participants randomized 1:1 that received BVd or DVd. A intravenous dose of 2.5 mg/kg of belantamab mafodotin was administered every three weeks in combination for the first eight cycles, after which it was continued as a single agent.
“In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favoring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm,” the press release stated.
The DREAMM-8 Phase III clinical trial was also a multicenter, open-label randomized trial that evaluated “belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy.” It included 302 participants randomized 1:1 to get either BPd or PVd, with 2.5 mg/kg of belantamab mafodotin given intravenously for the first cycle and then 1.9 mg/kg intravenously every four weeks.
“At the primary analysis at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5). A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned. With additional follow-up, a clinically meaningful benefit continued to be observed, with a near-tripling of the median PFS for the Blenrep combination versus the bortezomib combination (32.6 months versus 12.5 months, respectively (HR: 0.49 [95% CI: 0.35-0.68]). At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics,” the press release stated.
“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 stated in the press release (1).
The Blenrep combinations are approved already in the United Kingdom (since April 2025), Japan, Canada, Switzerland (DREAMM-8 only), and the United Arab Emirates. The European Union and China are also reviewing applications based on results from DREAMM-7, with breakthrough therapy designation for the combination and priority review for the application. In the UK, Blenrep is used for the treatment of adults with multiple myeloma in combination with bortezomib and dexamethasone for those who have received one prior therapy and in combination with pomalidomide and dexamethasone with receipt of a previous therapy.
“Blenrep is an ADC [antibody-drug conjugate] comprising a humanized BCMA [B-cell maturation antigen] monoclonal antibody [mAb] conjugated to the cytotoxic agent auristatin F via a non-cleavable linker,” GSK stated in the press release. Its linker technology is licensed from Seagen, with the mAb produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.
Multiple myeloma, according to GSK, is the third most common blood caner in the world. Approximately 180,000 new cases are diagnosed a year.
