The US Food and Drug Administration (FDA) has approved Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel) to treat acute lymphoblastic leukemia (ALL).
ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. Approximately 8,400 new cases of adult ALL are diagnosed every year in the US and EU. Approximately 3,000 of those patients relapse or are not successfully treated with standard of care therapies.
Aucatzyl, a CD19-directed CAR-T cell therapy has been specifically approved for use in adults with relapsed or refractory B-cell precursor ALL.
The CAR T-cell therapy was approved to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL) after showing complete remission in 63% of efficacy evaluable patients during Autolus’ FELIX clinical trial. 42% of patients achieved complete remission within three months and the median duration of response was 14.1 months, according to a press release from Autolus Therapeutics, the company that manufactures the therapy.
