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.
Related: Valuable Predictors Identified for Ide-Cel Therapy in Multiple Myeloma
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