Autolus Therapeutics (AUTL) said Friday that the UK Medicines and Healthcare products Regulatory Agency granted conditional marketing authorization for Aucatzyl to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The authorization is based on results from the Felix study, an open-label, multicenter, single-arm trial in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, according to the company.
The biopharmaceutical company said it submitted obecabtagene autoleucel, an autologous CD19 CAR T cell therapy with a proprietary CD19 CAR, for appraisal by the National Institute for Health and Care Excellence in Q4 2024.
Autolus is currently working with NICE and the NHS to potentially enable access for eligible patients in England.
Shares of Autolus were down 4.3% in recent trading.
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