Japan approves GSK’s Blenrep combinations for multiple myeloma

JAPAN—The Japanese Ministry of Health, Labour and Welfare (MHLW) has officially approved the use of GlaxoSmithKline’s (GSK) Blenrep (belantamab mafodotin) in combination therapies for adults with relapsed or refractory multiple myeloma (MM), a serious blood cancer.

This approval follows recent authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025, marking the second major regulatory clearance for these Blenrep combinations.

The decision by Japan’s MHLW is based on robust clinical evidence from two Phase III trials, DREAMM-7 and DREAMM-8.

These studies evaluated Blenrep combined with either bortezomib plus dexamethasone (BVd) or pomalidomide plus dexamethasone (BPd) in patients who had previously undergone at least one treatment for MM.

Both trials demonstrated superior efficacy compared to standard care, with DREAMM-7 showing a significant improvement in overall survival (OS) alongside progression-free survival (PFS), while DREAMM-8 confirmed meaningful PFS benefits.

Importantly, the safety and tolerability of the combinations were consistent with what is expected from the individual drugs involved.

This approval also follows Blenrep’s orphan drug designation in Japan, underscoring its potential to address a significant unmet medical need for patients with relapsed or refractory MM.

The designation highlights the therapy’s promise in extending remission and survival where current treatment options remain limited.

Globally, Blenrep combinations are under regulatory review in several key markets including the United States, China, the European Union, Switzerland, and Canada.

Notably, China has granted the application breakthrough therapy designation and priority review based on the DREAMM-7 results, while Switzerland has also accorded priority review status based on DREAMM-8 findings.

Hesham Abdullah, GSK’s global head of oncology R&D and senior vice-president, highlighted the importance of this approval, stating that Blenrep combinations offer patients additional treatment options at or after first relapse, with the potential to improve remission duration and survival compared to existing therapies.

 He also emphasized the convenience of in-office administration, which can be delivered in both academic and community healthcare settings.

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