Is Aucatzyl a new drug? Has it been approved for listing?

Aucatzyl, common name: obecabtagene Autoleucel, obe-cel) is a new type of CAR-T cellular immunotherapy that specifically targets the CD19 antigen and is mainly used to treat relapsed or refractory adult B cell acute lymphoblastic leukemia (r/r B-ALL).

Aucatzyl was approved for marketing by the US FDA in November 2024, becoming the fifth CD19 CAR-T therapy approved in the US. Its approval was based on the results of the FELIX clinical trial. Among 65 patients who were evaluable for efficacy, 63% achieved overall complete response (OCR< span>), including 51% of complete responses (CR) and 12% of complete responses with partial hematologic recovery (CRi). Additionally, 42%of patients achieved complete response within 3 months, and the median duration of response was 14.1 months.

Aucatzyl's design features include a faster off-target rate, which helps reduce overactivation of T cells and reduces the incidence of side effects. Compared with other CAR-T therapies, Aucatzyl is safer and does not require the implementation of risk assessment mitigation strategies (REMS). However, we still need to be alert to adverse reactions such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxic syndrome (ICANS).

Currently,AucatzylIt has not yet received marketing approval in mainland China. According to public information, WuXi Junuo has obtained the approval from the National Medical Products Administration of China (NMPA) on November 8, 2023. The approved CD19 targeted CAR-T product "Nacinolenza Injection" is used to treat adult relapsed or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). In the future, whether Aucatzyl will be launched in China still needs to wait for the review results of the relevant regulatory authorities.

Reference materials:https://www.drugs.com/