On September 15, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended non-renewal of marketing authorisation for belamaf mafadotin (Blenrep®).
Blenrep is currently approved for myeloma patients who have received at least four previous treatments and have stopped responding to at least one proteasome inhibitor (e.g., bortezomib), one immunomodulatory agent (e.g., lenalidomide), and an anti-CD38 monoclonal antibody (e.g., daratumumab), and whose cancer has worsened since receiving the last treatment.
GlaxoSmithKline (GSK), the company that manufactures Blenrep, have indicated they officially requested a re-evaluation of the CHMP recommendation and therefore, the current conditional marketing authorisation in the EU remains valid at this time, with no change in access for patients. Please speak to your haematologist if you are a patient and have any questions or concerns about what the EMA CHMP recommendation means for you.
Blenrep has been approved in the EU since August 2020 under a process called conditional approval. This means that the medicine was approved with earlier data, under the condition that the marketing authorisation would be reviewed every year as further data from Phase III clinical trials became available.
Conditional approval was granted for Blenrep based on DREAMM-2 clinical trial, a Phase II trial looking at two different doses of Blenrep monotherapy in relapsed and refractory myeloma patients.
The confirmatory study, requested by the EMA to support continued approval in the EU, was the DREAMM-3 clinical trial. This trial looked at Blenrep monotherapy compared to pomalidomide and dexamethasone in patients after three or more prior lines of therapy. DREAMM-2 final results and DREAMM-3 primary results were required to fulfil the EMA conditional approval. The results from the DREAMM-3 trial did not confirm improved effectiveness of Blenrep compared to pomalidomide and dexamethasone.
From publicly available information, we understand the CHMP recommendation was not related to concerns around the safety of the medicine for patients. In the EMA release, they highlight this as their main rationale:
“Patients who received Blenrep did not live longer without their disease getting worse than those who received pomalidomide plus dexamethasone. As this was the measure of effectiveness requested as part of the specific obligation, the medicine’s effectiveness could not be confirmed in its authorised use. Therefore, the CHMP recommended not renewing the marketing authorisation in the EU.” [EMA News, 15 September 2023]
What happens now?
GSK has indicated they have officially requested for re-examination of the CHMP opinion and therefore, the current conditional marketing authorisation in the EU remains valid at this time, with no change to access for patients. MPE will keep patients informed about the outcomes of this re-evaluation as it progresses over the coming months.
If you are a myeloma patient currently receiving Blenrep, you will continue to receive your treatment as usual. Please speak to your haematologist if you are a patient and have any questions or concerns about what this decision means for you.