Autolus Therapeutics Announces FDA Approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

Core Insights - The FDA has granted marketing approval for AUCATZYL (obecabtagene autoleucel), the first CAR T therapy without a REMS program, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][2] - The approval is based on the results from the FELIX clinical trial, which demonstrated significant efficacy and safety profiles for AUCATZYL [2][4] Company Overview - Autolus Therapeutics plc is an early commercial stage biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases [7] - AUCATZYL is the company's first commercial product, marking a significant milestone in its development journey [4] Clinical Trial Results - In the FELIX trial, 94 patients received AUCATZYL, with 63% achieving overall complete remission (OCR) and 42% achieving complete remission within 3 months [2][22] - The median duration of remission was reported at 14.1 months, indicating long-term efficacy [2][4] Safety Profile - AUCATZYL showed low levels of Cytokine Release Syndrome (CRS), with only 3% of patients experiencing Grade 3 events, and no Grade 4 or 5 events reported [2][3] - The most common adverse reactions included infections, musculoskeletal pain, and neurologic toxicities, with 64% of patients experiencing some form of neurologic toxicity [3][23] Manufacturing and Distribution - AUCATZYL will be manufactured at Autolus' dedicated site in Stevenage, UK, which has received necessary regulatory approvals [4] - Cardinal Health will serve as the commercial distribution partner in the U.S. [4] Market Context - Approximately 8,400 new cases of adult ALL are diagnosed annually in the US and EU, with around 3,000 patients in the relapsed refractory setting, highlighting a significant unmet medical need [5] - The approval of AUCATZYL is expected to address the poor survival rates in adult patients with r/r ALL, which currently stands at a median overall survival of eight months [5]