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Obecabtagene autoleucel granted marketing authorization by the European Commission for the treatment of R/R B-ALL
On July 21, 2025, the European Commission granted marketing authorization to obecabtagene autoleucel (obe-cel) for the treatment of adults aged ≥26 years with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (B-ALL).1
The approval is based on results from the phase Ib/II FELIX trial (NCT04404660), which demonstrated promising, durable response rates and low toxicity with obe-cel in adult patients with R/R B-ALL.1
Obe-cel is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, which was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with R/R B-ALL in November 2024 and holds a conditional marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the same indication.2
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On average, how many patients with T-cell acute lymphoblastic leukemia do you see in a year?
