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LONDON/GAITHERSBURG - The European Commission has granted marketing authorization for Autolus Therapeutics plc’s (NASDAQ:AUTL) AUCATZYL (obecabtagene autoleucel) for treating adult patients aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The company, currently valued at $641.4 million, has shown strong momentum with its stock delivering positive returns over the past three months, according to InvestingPro data.
The approval follows positive results from the FELIX clinical trial, which demonstrated a 76.6% complete response rate among the 94 patients in the pivotal cohort. The median response duration was 21.2 months, with median event-free survival of 11.9 months. InvestingPro analysis shows analysts are optimistic about the company’s prospects, with sales growth expected this year and a notably bullish consensus recommendation of 1.2 (where 1 is Strong Buy).
"AUCATZYL represents an important new treatment option for physicians treating adult r/r B-ALL patients," said Dr. Christian Itin, Chief Executive Officer of Autolus, according to the company’s press release statement.
The therapy is an autologous CD19 CAR T cell treatment with a proprietary design intended to mimic physiological T-cell receptor interactions. It was developed by a team led by Dr. Martin Pule at University College London.
In Europe, approximately 6,000 new cases of ALL are diagnosed annually. Up to 50% of adult B-ALL patients ultimately relapse after frontline treatment, with median overall survival of only eight months using conventional therapies.
The EC authorization applies to all 27 European Union Member States, Iceland, Norway, and Liechtenstein. AUCATZYL has previously received approval from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency.
The most common adverse reactions in the trial included infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%). Cytokine release syndrome occurred in 68.5% of patients, with grade 3 or higher events in 2.4%. Immune effector cell-associated neurotoxicity syndrome developed in 22.8% of patients, with 7% experiencing grade 3 or higher severity. For deeper insights into biotech companies like Autolus, including comprehensive financial health scores and detailed valuation metrics, explore the full research report available on InvestingPro, which covers over 1,400 US-listed companies.
In other recent news, Autolus Therapeutics has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its leukemia treatment, obecabtagene autoleucel (obe-cel). This recommendation follows the therapy’s prior approval by the U.S. Food and Drug Administration and a conditional marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency. The pivotal FELIX clinical trial demonstrated a 76.6% Complete Response/Complete Response with Incomplete Hematological Recovery rate among patients treated with obe-cel. The European Commission is expected to make a final decision on the conditional marketing authorization application for obe-cel within approximately two months. In a related development, the UK MHRA has granted a conditional marketing authorization for AUCATZYL® (obecabtagene autoleucel), noting the therapy’s potential to address unmet medical needs in serious diseases. The authorization requires an annual review of new efficacy and safety information. Autolus has submitted the treatment for appraisal by the National Institute for Health and Care Excellence, aiming to secure access for eligible patients in England.
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