Two belantamab mafodotin (Blenrep®) combinations, with bortezomib and dexamethasone or pomalidomide and dexamethasone, are now authorised for use in the European Union.

The decision follows an earlier positive recommendation of European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP – their scientific advisory committee) on 23 May 2025.

Marketing authorisation means that belantamab mafodotin is safe and effective for use in relapsed myeloma patients. However, it should be noted that national patient access will further depend on the company’s marketing decisions and on national healthcare system assessments and approvals.

The two phase III clinical trials (i.e., large studies comparing different treatments in patients) on which these approvals are based on are called DREAMM-7 and DREAMM-8. Both clinical trials found that belantamab mafadotin, when given in combination with existing myeloma drugs, extended the length of time myeloma patients had without their disease getting worse when compared to a standard of care (i.e., what patients might currently receive when they relapse).

Kate Morgan, co-CEO of Myeloma Patients Europe says about this approval:

“Myeloma is a complex cancer and the more treatments we have, including new mechanisms of action such as belantamab mafodotin, the more effectively we are able to treat it. This drug shows a significant anti-myeloma effect when used in combination with other myeloma treatments in the relapsed setting and we are working with members and other stakeholders to ensure access across Europe for patients who need it. Belantamab mafodotin is also associated with eye-related side-effects. Whilst these can be effectively managed using dosing amendments, and supportive care, we are working to educate patients and healthcare professionals (HCPs) to ensure they are appropriately managed to support patients’ quality of life.”

If you have any questions or require further information, please contact info@mpeurope.org