The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for the use of GSK’s Blenrep (belantamab mafodotin) combinations to treat adults with relapsed or refractory multiple myeloma (MM).
The decision is grounded in the positive outcomes from the Phase III DREAMM-7 and DREAMM-8 trials assessing Blenrep in conjunction with bortezomib plus dexamethasone (BVd) and with pomalidomide plus dexamethasone (BPd) respectively.
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MM subjects included in these trials had previously undergone at least one therapy.
The MHLW’s approval comes after orphan drug designation was awarded to the therapy in Japan, highlighting its potential to meet a significant unmet need for MM patients.
The Phase III trials demonstrated superior efficacy outcomes, including clinically meaningful progression-free survival (PFS) for the therapy combinations compared to standard care, as well as overall survival (OS) in the DREAMM-7 trial.
The tolerability and safety profiles of combinations were consistent with the profiles of the individual agents involved.
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By GlobalDataThe current approval marks the second major regulatory clearance for Blenrep combinations, following the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) authorisation in April 2025.
The combinations are undergoing review in worldwide markets, including the US, China, the European Union, Switzerland and Canada.
The Chinese application has been granted breakthrough therapy designation and priority review based on the DREAMM-7 outcomes, while Switzerland has accorded priority review based on the DREAMM-8 trial.
GSK research and development (R&D) oncology global head and senior vice-president Hesham Abdullah stated: “Today’s approval brings the benefits of Blenrep combinations to patients with relapsed or refractory multiple myeloma in Japan. Patients need additional treatment options at or after first relapse that can extend remission and survival versus standard of care.
“Blenrep combinations have the potential to redefine treatment outcomes based on superior efficacy shown in two Phase III trials, with the added advantage of in-office administration in both academic and community treatment settings.”
