On 21 September, the company that markets Blenrep asked for re-examination of the CHMP opinion.
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Upon receipt of the grounds of the request, the CHMP will re-examine its recommendation and issue a final recommendation.
Once the re-examination has been finalised, EMA will send the CHMP’s final opinion on the renewal application to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
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.
This type of authorisation allows a medicine to be authorised on the basis of less comprehensive (complete) data than are normally required, and when the benefits of having the medicine available earlier outweigh any risks associated with using it while waiting for further evidence.
Medicines with a conditional marketing authorisation are subject to specific post-authorisation obligations (such as a new study) that aim to generate comprehensive data on these medicines.
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.
IThe marketing authorisation for Blenrep will not be renewed and the medicine will no longer be available in the EU. ■