CHMP issues positive opinion for Blenrep combinations in relapsed/refractory multiple myeloma
Ella Day | May 23, 2025 | News story | Market & Product Development, Medical Communications, Research and Development |Â Â Blenrep, Committee for Medicinal Products for Human USE, European Medicines Agency, Oncology, multiple myelomaÂ
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Blenrep (belantamab mafodotin) in combination with either bortezomib and dexamethasone (BVd) or pomalidomide plus dexamethasone (BPd) for the treatment of adults with relapsed/refractory multiple myeloma.
The combinations are intended for patients who have received at least one prior therapy, with a European Commission decision expected later in 2025. The recommendation follows similar approvals in the UK and Japan earlier this year.
The CHMP opinion is supported by data from two phase 3 trials, DREAMM-7 and DREAMM-8, which both demonstrated improved progression-free survival for Blenrep combinations versus standard treatments. In DREAMM-7, Blenrep also showed an overall survival benefit compared with a daratumumab-based triplet. Safety and tolerability results were excellent.
If approved, Blenrep would become the first anti-BCMA antibody-drug conjugate authorised for use in combination regimens in Europe, offering a new treatment option for patients at first relapse. Approximately 50,000 people in Europe are diagnosed with multiple myeloma every year, with most experiencing relapse after initial treatment.
Blenrep combinations are under regulatory review in multiple markets, including the US, China, Canada and Switzerland.
Ella Day
23/5/25
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