BRIEF—Multiple myeloma drug Blenrep authorization should not be renewed, says EMA

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended that the conditional marketing authorization for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma, should not be renewed.

UK pharma major GSK, which markets the drug, already started taking Blenrep off the market in the USA in November 2022, due to a request from the US Food and Drug Administration (FDA) following the failure of the DREAMM-3 Phase III confirmatory trial, which failed to show that Blenrep was any better than on-market treatment.

In its review, the CHMP considered that results from a new study (DREAMM-3) did not confirm the effectiveness of Blenrep as agreed when conditional authorization was granted.

At the time of the initial authorization, no comparative data for Blenrep were available. As a specific obligation, the CHMP therefore requested the company marketing Blenrep to carry out a study to confirm the safety and effectiveness of the medicine by comparing it with pomalidomide plus low-dose dexamethasone, another authorized treatment for multiple myeloma that has come back and has not responded to treatment.