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FDA Approves Autolus' CAR-T Cell Therapy Aucatzyl for Relapsed/Refractory B-ALL

• The FDA has approved Autolus Therapeutics' Aucatzyl, a CAR-T cell therapy, for treating relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults. • Aucatzyl's approval was based on the FELIX clinical trial, which demonstrated encouraging remission rates and manageable side effects in adult r/r B-ALL patients. • This approval marks Autolus Therapeutics' first commercial product and provides a new treatment option for adult patients with r/r B-ALL in the US.

The FDA has granted marketing approval for Autolus Therapeutics' CAR-T cell therapy, AUCATZYL®, for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adult patients. This approval, which did not require a risk evaluation mitigation strategy, was based on the encouraging results of the FELIX clinical trial.

FELIX Trial Results

The FELIX clinical trial demonstrated encouraging remission rates and manageable side effects, leading to the FDA's decision to approve Aucatzyl. The trial provided critical data supporting the efficacy and safety of this novel CAR-T cell therapy in a challenging patient population.

Autolus Therapeutics' Perspective

"We are so pleased to now be able to offer AUCATZYL, our first commercial product, to adult r/r B-ALL patients in the US," said Christian Itin, CEO of Autolus. He also acknowledged the contributions of patients, families, caregivers, physicians, nurses, investigators, partners at University College London (UK), the internal team, external partners, and shareholders in achieving this milestone.

Significance of the Approval

This approval marks a significant advancement in the treatment landscape for adult patients with r/r B-ALL, offering a new therapeutic option with the potential for improved outcomes. Aucatzyl represents Autolus Therapeutics' first commercial product, highlighting the company's commitment to developing innovative cell therapies.
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Reference News

[1]
Cell Therapy Weekly: FDA Approves CAR-T Therapy for R/R B-ALL - RegMedNet
regmednet.com · Nov 15, 2024

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