GSK has announced that it has received the approval for Blenrep (belantamab mafodotin-blmf) as monotherapy for adult patients suffering from relapsed or refractory multiple myeloma. The drug is indicated for patients who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Currently, the product has received the accelerated approval, and continued approval will be given based on the clinical benefit demonstrated in the confirmatory trials.
The approval is based on the DREAMM-2 study. Blenrep 2.5 mg/kg was administered every three weeks, and the product has demonstrated a clinically meaningful overall response rate (ORR) in 31% of patients who received seven prior lines of treatment. 73% of the patients had a duration of response equal to or greater than six months; however, the median duration of response of six months had not been reached.
The drug is available in the BLENREP Risk Evaluation, and Mitigation Strategy developed to ensure the appropriate use of the drug.
In 2017, the drug received Breakthrough Therapy designation by the FDA.
The product has already received CHMP positive opinion in Europe in July.