NEW YORK – Casi Pharmaceuticals said on Wednesday that China's National Medical Products Administration (NMPA) approved inaticabtagene autoleucel as a treatment for relapsed and refractory B-cell acute lymphoblastic leukemia.
Inaticabtagene autoleucel is a CD19-directed autologous CAR T-cell therapy that Casi developed with Beijing-based Juventas Cell Therapy. The NMPA approved the treatment based on results from a Phase II clinical trial in 39 Chinese patients with B-cell acute lymphoblastic leukemia. In the study, 82.1 percent of patients responded after receiving inaticabtagene autoleucel, and 66.7 percent experienced a complete response within three months of getting the infusion. At 9.3 months of follow-up, the median duration of response was not reached.
In 2022, the US Food and Drug Administration granted inaticabtagene autoleucel orphan drug designation as a treatment for B-cell acute lymphoblastic leukemia.
Inaticabtagene autoleucel's approval in China is a milestone, according to Casi, since it is the first CD19-directed CAR T-cell product developed using independent Chinese intellectual property rights, and it is the first cell therapy launched in the Chinese market for B-cell acute lymphoblastic leukemia.
Casi, which has headquarters in both Beijing and Rockville, Maryland, is also developing the CAR T-cell therapy in B-cell non-Hodgkin lymphoma.