MHLW Reviews GSK's Multiple Myeloma Treatment NDA

Japan's Ministry of Health, Labour and Welfare (MHLW) has officially accepted GSK's new drug application (NDA) for Blenrep (belantamab mafodotin). This medication is aimed at treating patients suffering from relapsed or refractory multiple myeloma. The application has been bolstered by combining Blenrep with either bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex).

In a significant move, the MHLW has also granted Blenrep orphan drug designation for multiple myeloma indications, which ensures that the drug will receive priority review. This development marks the third major acceptance for combinations involving belantamab mafodotin. Previously, marketing authorization applications were accepted by both the European Medicines Agency and the UK's Medicines and Healthcare products Regulatory Agency.

The current application is backed by interim data from two Phase III clinical trials, known as DREAMM-7 and DREAMM-8. In the DREAMM-7 trial, the combination of belantamab mafodotin with BorDex was compared to the combination of daratumumab plus BorDex. Meanwhile, the DREAMM-8 trial assessed belantamab mafodotin with PomDex against bortezomib plus PomDex. Both trials reached their primary endpoints, showing significant improvements in progression-free survival when using Blenrep combinations as opposed to standard treatments.

Although the overall survival (OS) trend was positive in these interim analyses, it was not statistically significant at this point, and follow-up studies for OS are ongoing. Both trials also displayed improvements across all secondary efficacy endpoints, highlighting deeper and more durable responses. Additionally, the safety and tolerability profiles of the belantamab mafodotin combinations were consistent with those of the individual agents.

Blenrep is an antibody-drug conjugate that specifically targets the B-cell maturation antigen, a feature that makes it unique in its approach to treating multiple myeloma. Hesham Abdullah, head of GSK’s global research and development oncology unit, stated that the results from the DREAMM-7 and DREAMM-8 trials show the potential for Blenrep combinations to redefine the treatment landscape for relapsed or refractory multiple myeloma. He emphasized GSK's commitment to working with health authorities globally to expedite the regulatory process, aiming to provide these additional treatment options to patients as swiftly as possible.

In another noteworthy development, in August 2024, the MHLW approved GSK’s Nucala (mepolizumab) for treating adults with chronic rhinosinusitis with nasal polyps, particularly for those whose conditions are inadequately controlled with standard therapy.