EMA recommends NON-RENEWAL of authorisation of multiple myeloma medicine Blenrep (belantamab mafodotin)

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EMA’s CHMP has confirmed its initial recommendation to not renew the conditional marketing authorisation for GSK's Blenrep (belantamab mafodotin) because recent data did not confirm its effectiveness; the benefits of Blenrep are therefore considered to no longer outweigh its risks.

During a re-examination requested by GSK (cf. previous alert), the CHMP re-assessed the results from the DREAMM-3 study, which compared Blenrep with pomalidomide plus low-dose dexamethasone.

The study did not find that patients who received Blenrep lived longer without their disease getting worse when compared with patients who received pomalidomide plus dexamethasone. As confirming this progression-free survival was a requirement at the time of Blenrep’s initial authorisation, the Committee concluded that the data did not confirm the medicine’s benefits and recommended not renewing its authorisation.

During the re-examination, the CHMP consulted a scientific advisory group (SAG) comprising of experts in the treatment of cancer. These experts were of the view that the DREAMM-3 study did not confirm the effectiveness of Blenrep. However, the majority of SAG experts were also of the opinion that Blenrep could be a treatment option for some patients for whom other treatments were not suitable.

In reaching its final opinion, the CHMP considered the views of the SAG, the results of the DREAMM-3 study which failed to confirm the effectiveness of Blenrep, and the medicine’s safety profile.

All these considerations informed the CHMP’s conclusion that the benefits of Blenrep no longer outweigh its risks and its recommendation not to renew the medicine’s conditional marketing authorisation.

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EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer of the bone marrow).

Blenrep is given to adults who have received at least four previous treatments and whose disease does not respond to certain other types of cancer treatment, and whose cancer has worsened since receiving the last treatment.

This recommendation follows a review of available data by the CHMP as part of the renewal of Blenrep’s marketing authorisation. 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 marketing authorisation was granted.

Because Blenrep was meant to address an unmet medical need for a serious disease, it received a conditional marketing authorisation in August 2020. At the time of the initial authorisation, 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 authorised treatment for multiple myeloma that has come back and has not responded to treatment. 

The study found that 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.

In its review the CHMP also consulted patient representatives and experts in the treatment of cancer and took their views into consideration when reaching its opinion. EMA will now send the CHMP’s opinion to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. 

The marketing authorisation for Blenrep will not be renewed and the medicine will no longer be available in the EU. 

Healthcare professionals should not start any new patients on Blenrep. For patients currently using Blenrep, healthcare professionals should explain to patients that the medicine is no longer available and discuss with them suitable treatment alternatives.

More about the medicine

Blenrep is a monoclonal antibody attached to a cytotoxic (cell-killing) molecule. It targets a protein called B-cell maturation antigen (BCMA), which is present on the surface of the multiple myeloma cells. By attaching to BCMA, the medicine releases the cytotoxic molecule into the cells to kill the multiple myeloma cells.