FDA Approval Boosts Autolus' CAR-T Aucatzyl in Competitive Leukemia Market

Autolus Therapeutics has achieved a pivotal milestone with the FDA's approval of its CAR-T cell therapy, Aucatzyl, for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). This approval follows significant results from the FELIX study, where Aucatzyl demonstrated a 63% complete remission rate among evaluable patients and showcased a favorable safety profile with lower severe cytokine release syndrome levels[1][2]. Notably, Aucatzyl distinguishes itself in the market by being the only CAR-T therapy in its class that does not require an FDA Risk Evaluation Mitigation Strategy (REMS), simplifying the treatment process for centers and potentially accelerating its adoption[1]. Additionally, priced at $525,000, Aucatzyl is positioned to be a competitive rival to Gilead's Tecartus, with plans to initially launch in 30 U.S. treatment centers and later expand[2].