Autolus Therapeutics announces FDA approval of Aucatzyl

On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics (Nasdaq: AUTL), whose share rose more than 8% to 44.03 on the news.

Aucatzyl is a CD19-directed genetically modified autologous T cell immunotherapy, now authorized for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

The FDA noted that the prescribing information has a boxed warning for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and T cell malignancies. CRS occurred in 75% (Grade 3, 3%) and neurologic toxicities occurred in 64% (Grade ≥3, 12%), including ICANS in 24% (Grade ≥3, 7%).