FDA Approved New CAR-T, Earlier Lines of Treatment in Other Similar Agents
-
Feb 13, 2025
Chimeric antigen receptor T cell (CAR-T) therapies had quite the year in 2024, with the first approval of a new agent in nearly three years, as well as a handful of expanded indications, including two that moved the moved the agents into an earlier line of treatment.
On Nov. 8, 2024, the FDA approved Autolus Therapeutics plc’s Aucatzyl (obecabtagene autoleucel) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. That marked the first new CAR-T since the Feb. 28, 2022, approval of Carvykti (ciltacabtagene autoleucel) from the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc. While Aucatzyl shares similar black box warnings about cytokine release syndrome (CRS), neurologic toxicities and secondary hematological malignancies as the other CAR-Ts, Autolus noted that the new therapy is the first such agent approved without a Risk Evaluation Mitigation Strategy (REMS) program.
Read more
© 2024 MMIT
The Latest
Meet Our Reporters
Meet Our Reporters
GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND
Sign up for publications to get unmatched business intelligence delivered to your inbox.