FDA Advisory Panel Votes in Favor of Approving Belantamab Mafodotin in Myeloma
Posted: Wednesday, July 22, 2020
On July 14, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee unanimously voted in favor of approving belantamab mafodotin as treatment for patients with multiple myeloma who had received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Despite safety concerns of keratopathy by the FDA, the independent panel reasoned the benefits of belantamab mafodotin monotherapy outweighed its risks.
In 2017, belantamab mafodotin received Breakthrough Therapy designation, and Priority Review designation was issued by the FDA earlier this year. If approved, belantamab mafodotin will be the first-in-class anti-BCMA therapy for relapsed or refractory multiple myeloma
The independent panel recommendation was based on the efficacy data from the mid-stage, open-label DREAMM-2 clinical trial. The study recruited nearly 100 patients with progressing multiple myeloma that had worsened despite the current standard of care. Patients were given either 2.5 mg/kg or 3.4 mg/kg of belantamab mafodotin every 3 weeks.
The 6-month primary results showed a 31% meaningful response to the drug, but 27% of patients experienced medically severe keratopathy. Although no life-threatening symptoms were reported, one patient discontinued treatment because of side effects. Despite the results, patients in DREAMM-2 had more advanced disease, poorer prognosis, and a greater number of prior lines of therapy in comparison with patients treated with belantamab mafodotin in the DREAMM-1 study.
