Panel to Weigh Future of Multiple Myeloma Therapy

Federal Register notice: FDA has announced a 10/28 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the accelerated approval of an Oncopeptides NDA for Pepaxto (melphalan flufenamide) for injection for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. They will hear an update where a required confirmatory trial demonstrated a worse overall survival in the melphalan flufenamide treatment arm compared to the control arm. Discussions will be focused on next steps for the product including whether the indication should remain on the market while additional trials are conducted. To view the notice, click here.