By Patrick Daly - Last Updated: April 5, 2024
The US Food and Drug Administration (FDA) has approved idecabtagene vicleucel (ide-cel) in adult patients with relapsed or refractory multiple myeloma (MM) after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, according to a press release from Bristol Myers Squibb and 2seventy bio, Inc.
The FDA approval updated the indication for ide-cel to allow its use in earlier lines of therapy among triple-class exposed patients with MM.
The expansion of the indication was supported by positive data from the KarMMa-3 study. “The results of the KarMMa-3 study are remarkable,” stated Al-Ola Abdallah, MD, of the University of Kansas. “With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach.”
Ide-cel is also approved after two or more prior lines of therapy for triple-class exposed adult patients with relapsed or refractory multiple myeloma in Japan, Switzerland, and the European Union, and after three or more prior lines in Great Britain and Israel.
Original Source: Ide-Cel Approved for Triple-Class Exposed Myeloma After Two Prior Lines in United States | Blood Cancers Today