Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple myeloma accepted for regulatory review in Japan

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma. MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma.

This is the third major regulatory filing acceptance for belantamab mafodotin combinations in the treatment of relapsed/refractory multiple myeloma, following marketing authorisation application acceptance by the European Medicines Agency (EMA) in July 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK earlier this month.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “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.”

Multiple myeloma presents a growing health concern in Japan, where the number of patients diagnosed with multiple myeloma per year has increased continuously over the last five decades. This underscores the urgent need for more treatment options for patients in Japan, particularly those with progressing disease that has become resistant to the current standard of care.

The application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care combinations in relapsed or refractory multiple myeloma. A positive overall survival (OS) trend was observed in both trials but was not statistically significant at the time of interim analysis. Follow-up for OS continues. The DREAMM-7 trial is evaluating belantamab mafodotin combined with BorDex versus daratumumab plus BorDex, while the DREAMM-8 trial is evaluating belantamab mafodotin in combination with PomDex versus bortezomib plus PomDex.

Results from both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses compared to the respective standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in DREAMM-7 and DREAMM-8 trials were broadly consistent with the known profiles of the individual agents.