The European Medicines Agency (the EU medicines regulator) Committee for Medicinal Products for Human Use (CHMP) has today confirmed their earlier recommendation to not renew marketing authorisation for belamaf mafadotin (Blenrep®). The confirmation follows a review of the CHMP decision, requested by the manufacturer GSK.

MPE Co-Chief Executive Officer, Kate Morgan, commented: “The final recommendation from the EMA CHMP is a disappointing one. Whilst we understand the limitations from the DREAMM-3 clinical trial data, we know that patients were benefitting from access to Blenrep in this heavily pre-treated setting – particularly where they were unable to access or tolerate other BCMA targeting therapies. At MPE, we are working to understand the full implications of this decision and to ensure that patients currently being treated with Blenrep continue to do so.”

The decision means that the EU marketing authorisation for Blenrep will be removed once it is ratified by the European Commission. The manufacturer, GSK, has confirmed that they will continue to provide the medicine to patients who are already receiving it. See the below Q&A for further information.

How was Blenrep initially approved?

Blenrep was initially approved in the EU 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.

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.

Blenrep is currently reimbursed (funded), in line with the marketing authorisation, across several European countries and is also provided to patients in some countries through a “named patient programme” (i.e. doctors are able to request it for their patients).

What does the decision mean?

The European Commission will confirm the CHMP decision within 67 days. Once confirmed, Blenrep will no longer have marketing authorisation from the EU. The reimbursement of Blenrep in some EU countries is also likely to end.

What about patients currently receiving Blenrep?

GSK has confirmed that patients currently receiving Blenrep will not have their treatment stopped.

Supply of Blenrep will be maintained for these patients for as long as they need it through the Blenrep named patient programme. However, no new patients will be provided access to Blenrep through the programme.

If you have any questions or concerns about your treatment, please speak to your doctor.

Why has the CHMP committee made this decision?

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 CHMP committee, in both the initial and review meetings, concluded that the results from the DREAMM-3 trial did not confirm improved effectiveness of Blenrep compared to pomalidomide and dexamethasone. Whilst this is the case, a range of experts in a “Scientific Advisory Group” (SAG – includes clinical and patient representatives) meeting, convened to support the CHMP decision-making, agreed that Blenrep has a role to play in this setting, particularly for a specific group of patients.

What next for Blenrep?

The decision of the EMA only applies to the Blenrep monotherapy setting in the DREAMM-2 and DREAMM-3 clinical trials. There are a number of ongoing trials looking at Blenrep in combination with other effective myeloma drugs. Two such trials are:

• DREAMM-7 trial, looking at Blenrep in combination with bortezomib and dexamethasone compared to daratumumab (Darzalex®) bortezomib and dexamethasone in relapsed/refractory myeloma patients. You can see the most recent results covered here.
• DREAMM-8 trial, looking at Blenrep in combination with pomalidomide and dexamethasone compared to pomalidomide, bortezomib and dexamethasone in relapsed/refractory myeloma patients.

If the results of these trials are positive, such as the recently published results of the DREAMM-7 trial, it is likely we will see additional marketing authorisation applications to the EMA in the coming years.

Where can I find further information?

If you have any questions or comments, please email info@mpeurope.org

If you are a patient currently receiving, or waiting to receive, Blenrep please speak to your doctor about the decision and what it means for your treatment.

You can read the EMA CHMP decision here.