On the 23 May 2025, the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of two belantamab mafodotin combinations for the treatment of patients with relapsed and/or refractory myeloma.

The first combination is with bortezomib (a proteasome inhibitor) plus the steroid dexamethasone (BVd) in patients who have received at least one prior therapy. The second one is with pomalidomide (an immunomodulatory drug) plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide (an immunomodulatory drug or IMiD).

The CHMP is the European Medicines Agency’s (the medicines licensing body in the EU) committee responsible for scientific opinions on new medicines. Based on these opinions, the European Commission (EC) will decide whether or not to authorise these combinations for use in European patients.  Now, the EC has approximately 60 days in which to consider and adopt the CHMP recommendation.

If approved, the belantamab mafodotin combinations (marketed by GSK as Blenrep®), could represent further treatment options for European patients at second line and beyond. However, national patient access also depends on GSK marketing decisions and on national healthcare system assessment and approval.

How does belantamab mafodotin work?

Belantamab mafodotin is an antibody drug conjugate medication. It consists of a monoclonal antibody (a laboratory engineered antibody) which is bound to a chemotherapy agent that has been designed to recognise and bind to the BCMA protein, found on the surface of myeloma cells. By attaching to it, this drug is then taken inside the cells, releases the chemotherapy agent, and directly kills the myeloma cell. This also activates the immune system to find and destroy more myeloma cells.

What data is the approval based on?

The CHMP recommendation is based on the results of two phase III clinical trials, DREAMM-7 and DREAMM-8, which studied belantamab mafodotin-based combinations in second line and beyond.

DREAMM-7

This clinical trial examined the combination BVd compared to daratumumab (an anti-CD38 monoclonal antibody medication), bortezomib and dexamethasone (DVd).

Treatment with BVd was shown to result in longer periods where patients were free from myeloma when compared to DVd. There were a higher number of patients alive after 18 months in the BVd group (84% vs 73%). Eye-related side effects (such as blurred vision and dry eyes), associated with belantamab mafadotin, were more common in the BVd group than in the DVd group (79% vs. 29%). These were mostly managed with dose modifications.

DREAMM-8

This clinical trial examined the combination BPd compared to pomalidomide, bortezomib and dexamethasone (PVd).

Treatment with BPd was shown to lower the risk of myeloma progression or death compared to PVd. After 12 months, 71% of patients treated with BPd did not see their disease worsen, compared to 51% of patients in the PVd group. Among those who took BPd, 89% had eye-related side effects, with 43% of those being more severe. In comparison, 30% of PVd patients had eye-related side effects, 2% being severe. Again, these were mostly managed with dose modifications. 82% of patients from the BPd group experienced infections compared with 68% in the PVd group. In both treatment groups, 11% of patients died due to serious adverse events (i.e. serious side-effects).

Further information

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

You can see the GSK press release here.