GSK plc has disclosed that the United States Food and Drug Administration (FDA) has agreed to review the Biologics License Application (BLA) for Blenrep (belantamab mafodotin) when combined with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]). This is intended for the treatment of multiple myeloma patients who have undergone at least one previous therapy. The FDA has established a Prescription Drug User Fee Act decision date of July 23, 2025.
Hesham Abdullah, who serves as Senior Vice President and Global Oncology Research & Development Head at GSK, stated: “The availability of effective treatment options for those with relapsed/refractory multiple myeloma with manageable side effects represents a milestone in therapy. The DREAMM-7 and DREAMM-8 trials provide compelling evidence supporting our combination treatment with Blenrep. We’re eager to collaborate with the FDA during this review process.”
The U.S. application draws from the results of the DREAMM-7 and DREAMM-8 phase III trials. These trials successfully met their key objectives, demonstrating improvements in progression-free survival for belantamab mafodotin combinations versus the standard triplet therapy in relapsed or refractory multiple myeloma.
The trials also indicated significant improvements in secondary efficacy endpoints, demonstrating deeper, sustained responses over standard therapy combinations. The safety profiles of belantamab mafodotin in these trials matched well with established profiles of each individual component.
In an interim evaluation, the DREAMM-7 trials also met secondary objectives in terms of overall survival, displaying significant benefit for those on the belantamab mafodotin combination. Detailed data is set to be presented at the American Society of Hematology’s meeting on December 9, 2024. While the DREAMM-8 showed positive trends for overall survival at the interim stage, this was not statistically significant, and observations are ongoing.
This marks the sixth major regulatory submission acceptance for Belantamab mafodotin combinations targeting relapsed or refractory multiple myeloma, following evidences from DREAMM-7 and DREAMM-8. For 2024, submissions have been accepted in regions including European Union, Japan with priority review, Canada, the UK, and Switzerland, with China designating it as a breakthrough therapy and giving it priority review.
Multiple myeloma is a prevalent blood cancer worldwide, generally treatable but not curable, with over 180,000 new cases annually. It’s a persistent health challenge in the U.S., where 35,000 new cases are expected in 2024, necessitating continued research for refractory cases.
The DREAMM-7 trial is a multicenter, open-label, randomized study assessing the effectiveness and safety of belantamab mafodotin with bortezomib and dexamethasone against a combination of daratumumab, bortezomib, and dexamethasone in relapsed/refractory cases. Participants previously documented disease progression after prior therapy.
In this trial, 494 participants were divided equally between the BVd and DVd treatment groups, receiving Blenrep doses every three weeks. Primary endpoint measures include progression-free survival, with key secondary measures involving overall survival, duration of response, and minimal residual disease negativity rates.
Initial results were presented at the ASCO Plenary Series in early 2024, with subsequent presentations and publications in established journals.
The DREAMM-8 trial similarly investigates belantamab mafodotin with pomalidomide and dexamethasone against bortezomib, pomalidomide, and dexamethasone, targeting a similar, pre-treated demographic differing in lenalidomide exposure.
Here, 302 participants were equally assigned to the BPd or PVd cohorts.
Blenrep functions as an antibody-drug conjugate consisting of a humanized B-cell maturation antigen monoclonal antibody linked to the cytotoxic molecule auristatin F. The linker technology is licensed from Seagen Inc., with production using BioWa Inc’s POTELLIGENT Technology.
Blenrep has reached approval status for monotherapy in Hong Kong, and GSK remains committed to maximizing patient survival through advances in hematological and solid tumor oncology. GSK’s mission is to use scientific and technological innovation to advance global health.