Autolus Therapeutics plc, a biopharmaceutical company, has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use $(CHMP)$ has recommended the European Commission $(EC)$ approve obecabtagene autoleucel (obe-cel) for adult patients aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This recommendation is based on the FELIX clinical trial, which demonstrated high response rates and low toxicity. The EC's decision on the conditional marketing authorization application is anticipated within two months, following the positive CHMP opinion. Obe-cel has already received approval from the U.S. Food and Drug Administration (FDA) in November 2024 and a conditional marketing authorization from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025. The EC decision will be applicable to all 27 European Union Member States, Iceland, Norway, and Liechtenstein.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.