Syncona Ltd (SYNC.L) said that its portfolio company Autolus Therapeutics announced that the U.S. Food and Drug Administration has granted marketing approval for AUCATZYL (obe-cel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL).
AUCATZYL was approved by the FDA based on results from the FELIX clinical trial of obe-cel in adult patients with r/r B-ALL.
AUCATZYL will be manufactured at Autolus' dedicated commercial manufacturing site, the Nucleus, in Stevenage, UK.
Autolus noted that Marketing authorisation applications (MAAs) for obe-cel in adult r/r ALL are being reviewed by the regulators in both the EU and the UK, with a submission to the European Medicines Agency (EMA) accepted in March 2024, and a submission accepted by the UK MHRA in August 2024.
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