FDA Panel Gives Thumbs Up to Earlier Use of CAR T-Cell Therapy in Multiple Myeloma
Two CAR T-cell therapies for multiple myeloma won favorable recommendations for earlier use in the disease during a day-long meeting of the FDA Oncologic Drugs Advisory Committee (ODAC). By an 11-0 vote, ODAC recommended that FDA approve ciltacabtagene autoleucel (cilta-cel, Carvykti) for use as second-line therapy in certain patients with myeloma. Later in the day, […]
Year in Review: Multiple Myeloma
Developments in multiple myeloma over the past year were marked by the approvals of a first-in-class drug for relapsed or refractory disease and a second chimeric antigen receptor (CAR) T-cell therapy, as well as some encouraging news and disappointments on the research front. New Approvals Last month, the FDA granted accelerated approval to teclistamab (Tecvayli) […]
FDA Broadens Options for Relapsed/Refractory Multiple Myeloma With Teclistamab
Treatment options for relapsed/refractory multiple myeloma continue to expand with FDA’s accelerated approval of teclistamab (Tecvayli). The approval stipulates use of the bispecific antibody in adults who have received at least four prior therapies, including an immunomodulator, a proteasome inhibitor, and an anti-CD38 antibody (triple-class refractory disease). The first approved drug of its kind, teclistamab […]