Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review GSK‘s new drug application (NDA) for Blenrep (belantamab mafodotin) to treat patients with relapsed or refractory multiple myeloma.
The NDA includes a combination of Blenrep with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex).
The MHLW also granted orphan drug designation to Blenrep for multiple myeloma indications, ensuring a priority review.
This is the third major acceptance for belantamab mafodotin combinations, after the marketing authorisation application acceptance by the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency.
The latest application is supported by interim data from the DREAMM-7 and DREAMM-8 Phase III clinical trials.
In the DREAMM-7 trial, belantamab mafodotin combined with BorDex was evaluated against daratumumab plus BorDex.
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The DREAMM-8 trial compared belantamab mafodotin with PomDex against bortezomib plus PomDex.
These trials met their primary endpoints, demonstrating significant improvements in progression-free survival with the Blenrep combinations compared to standard care.
Although the overall survival (OS) trend was positive, it was not statistically significant at interim analysis, with further follow-up for OS ongoing.
Both trials also reported improvements across all secondary efficacy endpoints, including deeper and more durable responses.
The safety and tolerability profiles of the belantamab mafodotin combinations in both trials were in line with those of the individual agents.
Blenrep is an antibody-drug conjugate that targets the B-cell maturation antigen.
GSK research and development oncology global head and senior vice-president Hesham Abdullah stated: “Blenrep combinations show potential based on the results of the DREAMM-7 and DREAMM-8 trials to redefine the treatment of relapsed/refractory multiple myeloma.
“We are committed to working with health authorities worldwide to advance Blenrep along regulatory pathways so we can bring these additional treatment options to patients as quickly as possible.”
In August 2024, the MHLW approved GSK’s Nucala (mepolizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps whose condition is inadequately controlled with standard therapy.
