HQ Team
September 15, 2023: The European Medicines Agency has recommended the stoppage of conditional marketing authorisation for GSK’s Blenrep (belantamab mafodotin), a medicine used to treat cancer of the bone marrow.
The move follows a review of available data by the Committee for Medicinal Products for Human Use (CHMP) as part of the renewal of Blenrep’s marketing authorisation.
The British drugmaker, GSK, stopped selling the medicine for treating multiple myeloma, in the US in 2022 at the request of the Food and Drug Administration.
In its review, the CHMP considered that results from GSK’s late-stage experimental study, known as DREAMM-3, did not confirm the effectiveness of Blenrep as agreed when the authorisation was granted, according to an EMA statement.
Unmet medical need
Blenrep was given to adults who had received at least four previous treatments and whose disease does not respond to certain other types of cancer treatment. It was also given to adults whose cancer has worsened since receiving the last treatment.
As Blenrep was meant to address an unmet medical need for a serious disease, it received a conditional marketing authorisation on August 25, 2020.
The marketing authorisation was subject to annual renewals based on the results of additional studies imposed on the marketing authorisation holder.
At the time of the initial authorisation, no comparative data for Blenrep were available. The CHMP requested the company marketing Blenrep to carry out a study to confirm the safety and effectiveness of the medicine by comparing it with existing ones.
Didn’t live longer
The study found that patients who received Blenrep did not live longer without their disease getting worse than those who received pomalidomide plus dexamethasone, the existing medicines.
“The medicine’s effectiveness could not be confirmed in its authorised use. Therefore, the CHMP recommended not renewing the marketing authorisation in the EU,” according to the statement.
The European Union drug regulator stated that in its review the CHMP consulted patient representatives and experts in the treatment of cancer and took their views into consideration when reaching its opinion.
The EMA will now send the CHMP’s opinion to the European Commission, which will issue a final legally binding decision applicable to all EU Member States.
Rare cancer
Multiple myeloma, a cancer of the bone marrow, is a rare cancer of a type of white blood cells called plasma cells.
Normal plasma cells are found in the bone marrow and are an important part of the immune system.
When plasma cells become cancerous, they no longer protect the body from infections and produce abnormal proteins that can cause problems affecting the kidneys, bones or blood.
GSK has 15 days to submit for a re-examination of the recommendation.
The medicine will no longer be available in the EU Member States following the non-renewal of its conditional marketing authorisation.
