GSK Says BLENREP Gets EU Approval To Treat Relapsed And Refractory Multiple Myeloma

(RTTNews) - GlaxoSmithKline plc (GSK.L, GSK) announced Thursday the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma.

BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved in the European Union. The EU marketing authorisation follows the recent US approval of BLENREP.

The approval is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, including 13-month follow-up data.

BLENREP received approval as monotherapy for the treatment of multiple myeloma in adult patients 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 drug is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care.

In Europe, nearly 50,000 new cases of multiple myeloma are diagnosed each year. Most of these patients will relapse or stop responding to current therapies.

Katja Weisel, an investigator for the DREAMM-2 trial, said, "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."