Autolus Wins OK for Leukemia CAR-T Theray

FDA has approved an Autolus Therapeutics BLA for Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

The product was approved based on data from the company’s FELIX clinical trial. “In the efficacy evaluable patients (n=65), 63% achieved overall complete remission (OCR),” the company says. “The major efficacy outcome was complete remission within three months, which was achieved in 42% patients, and the median duration of remission (DOR) was 14.1 months.”

The company notes that Aucatzyl showed low levels of Cytokine Release Syndrome (3% Grade 3 events, and no Grade 4 or 5 events). Grade 3 or higher immune effector cell-associated neurotoxicity syndrome was reported in 7% of patients, it says, but no FDA-mandated risk valuation and mitigation strategy was required under the approval.