FDA Approves Belantamab Mafodotin-blmf for Treatment of Patients with Relapsed, Refractory Multiple Myeloma

Officials from the FDA have granted accelerated approval to belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent, according to a press release.

The accelerated approval is based on overall response rate (ORR), as continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. According to the press release, belantamab mafodotin-blmf is the first anti-B cell maturation antigen (BCMA) therapy approved anywhere in the world.

“As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease,” said Hal Barron, MD, chief scientific officer and president R&D at GSK, in a press release. “Blenrep is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today.’’

The approval of belantamab mafodotin-blmf was based on the 6-month primary results from the pivotal DREAMM-2 study. The study enrolled patients with RRMM who had actively progressing disease that had worsened despite current standard of care.

Treatment with single-agent belantamab mafodotin-blmf 2.5 mg/kg every 3 weeks demonstrated a clinically meaningful ORR of 31% in patients who had received a median of 7 prior lines of treatment, according to the press release. The median duration of response (DoR) had not been reached at the 6-month analysis, but 73% of responders had a DoR equal to or greater than 6 months.

The most commonly reported adverse events were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. Ocular adverse reactions were reported in 77% of patients in the pooled safety population, which included keratopathy, changes in visual activity, blurred vision, and dry eye.

REFERENCE

FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma. GSK. https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-blenrep-belantamab-mafodotin-blmf-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/. Published August 6, 2020. Accessed August 6, 2020.