GSK bags EU approval for Blenrep

Hot on the heels of US approval GlaxoSmithKline has now also bagged a nod in Europe for Blenrep (belantamab mafodotin-blmf) as a treatment for patients with relapsed for refractory multiple myeloma (MM).

Blenrep is a first-line inhibitor of BCMA, a cell-surface protein that plays a crucial role in the survival of plasma cells and is expressed on multiple myeloma cells.

In the pivotal DREAMM-2 study, treatment with a Blenrep dose of 2.5mg/kg every three weeks resulted in an overall response rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months.

On the back of these findings, EU regulators have granted Blenrep a conditional marketing authorisation for the treatment of MM in adults who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

“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.”

“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,” added Dr Katja Weisel, deputy director and Associate Professor of Haematology/Oncology in the Department of Oncology, Haematology and Bone Marrow Transplantation with Department of Pneumonology, University Medical Centre Hamburg-Eppendorf in Germany and an investigator for the DREAMM-2 trial.