FDA Approves Autolus Therapeutics' Aucatzyl for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia Under FELIX Program

Nov 8, 2024, 09:24 PM

The U.S. Food and Drug Administration (FDA) has approved Autolus Therapeutics' Aucatzyl (obecabtagene autoleucel – obe-cel) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This approval, part of the FELIX program, marks a significant milestone for the company and provides a new treatment option for patients suffering from this aggressive form of leukemia. Despite earlier rumors and a temporary dip in share prices, the official announcement has confirmed the FDA's decision, which is expected to positively impact Autolus Therapeutics' market position.