July 24, 2025—According to a press release from GSK, Blenrep (belantamab mafodotin) has been approved "in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide. The approval is based on superior efficacy results demonstrated by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma."

The DREAMM-7 and DREAMM-8 trials showed that Blenrep combinations significantly improved progression-free survival (PFS) compared to standard-of-care triplets. In DREAMM-7, Blenrep nearly tripled median PFS and reduced the risk of death by 42% versus a daratumumab-based combination. In DREAMM-8, median PFS was not yet reached for Blenrep, while the comparator showed a median PFS of 12.7 months.

Blenrep is the only approved anti-BCMA antibody-drug conjugate in multiple myeloma, offering a unique way to help slow disease progression and improve survival. The treatment showed benefit across a wide range of patient groups, including those with high-risk features or lenalidomide resistance. Patients also experienced deeper and longer-lasting responses compared to existing treatments.

The safety profile of Blenrep combinations was consistent with the known side effects of the individual drugs. Eye-related side effects were manageable with dose adjustments, and rates of treatment discontinuation due to these effects were low (≤9%). Common non-eye-related side effects included thrombocytopenia, diarrhoea, neutropenia, and COVID-19 infection.

Blenrep combinations are already approved in several other countries, including the UK, Japan, Canada, and Switzerland, with regulatory reviews ongoing in the US, China, and other global markets.