Blenrep granted CMA for relapsed or refractory multiple myeloma
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
Bone marrow aspirate cytology of multiple myeloma, a type of bone marrow cancer of malignant plasma cells, associated with bone pain, bone fractures and anemia.
The European Commission (EC) has granted a conditional marketing authorisation for GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) as a treatment for adult patients with relapsed or refractory multiple myeloma (MM).
The approval allows Blenrep to be used as a monotherapy treatment in adult patients who have had at least four prior therapies including one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody. The drug is an antibody-drug conjugate which inhibits anti-B cell maturation antigen (BCMA), a cell-surface protein that plays a crucial role in the survival of plasma cells and is expressed on MM cells.
The approval was based on data from the DREAMM-2 study, in which treatment with a Blenrep dose of 2.5mg/kg every three weeks resulted in an overall response rate of 32 percent. The enterprise also reported that the median duration of response was 11 months and median overall survival was 13.7 months.
GSK R&D president and chief scientific officer, Dr Hal Barron said: “The approval of BLENREP marks an important step forward for patients in Europe where nearly 50,000 new cases of multiple myeloma are diagnosed each year. Unfortunately, most of these patients will relapse or stop responding to current therapies so I am pleased that [the approval] will give patients with limited treatment options access to the first approved anti-BCMA therapy.”
Dr Katja Weisel, deputy director and Associate Professor of Haematology/Oncology in the Department of Oncology, Haematology and Bone Marrow Transplantation, University Medical Centre Hamburg-Eppendorf, Germany, and an investigator for the DREAMM-2 trial added: “Despite advances in treatment, multiple myeloma remains incurable and patients continue to cycle through therapies, with their prognosis worsening with each relapse. The approval of BLENREP, with its novel mechanism of action, represents a new class of treatment that patients can turn to when their cancer stops responding to other standard of care options.”