FDA Accepts GSK's Blenrep Combinations for Relapsed/Refractory Multiple Myeloma Treatment
Key Insights
The FDA has accepted GSK's Biologics License Application for Blenrep (belantamab mafodotin) combined with BorDex and PomDex.
The application targets multiple myeloma (search) patients who have undergone at least one prior line of therapy, potentially redefining treatment.
The acceptance is based on DREAMM-7 and DREAMM-8 phase III trials, demonstrating significant improvements in progression-free survival.
GSK's Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) has been accepted for review by the US Food and Drug Administration (FDA) as a treatment for patients with relapsed or refractory multiple myeloma (search) who have received at least one prior line of therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2025.
The Biologics License Application (BLA) is supported by results from the DREAMM-7 and DREAMM-8 phase III trials, both of which met their primary endpoints. These trials demonstrated 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 (search).
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, stated that the Blenrep combinations could transform the treatment landscape for relapsed/refractory multiple myeloma (search) by providing additional efficacious treatment options with manageable side effects and community-based administration. He also noted that the statistically significant overall survival results from the DREAMM-7 trial further strengthened the evidence supporting the submission.
DREAMM-7 and DREAMM-8 Trial Data
The DREAMM-7 trial is a Phase III, open-label, randomized study evaluating belantamab mafodotin plus bortezomib and dexamethasone (BVd) versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma (search) who have received at least one prior line of therapy. The primary endpoint is progression-free survival (PFS).
The DREAMM-8 trial is a Phase III, open-label, randomized study comparing belantamab mafodotin plus pomalidomide and dexamethasone (BPd) versus pomalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma (search) who have received at least one prior line of therapy. Similar to DREAMM-7, the primary endpoint is PFS.
Regulatory Landscape
This marks the sixth major regulatory filing acceptance this year for belantamab mafodotin combinations in the treatment of relapsed or refractory multiple myeloma (search), based on the DREAMM-7 and DREAMM-8 trials. In 2024, belantamab mafodotin combinations have been accepted for review in the European Union, Japan (with priority review), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8). Furthermore, in China, 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.