Novartis Receives CDE Approval for New Clinical Trial of BCR-ABL Allosteric Inhibitor Asciminib in China

Intelligent Finance APP learned on October 12 that, according to the CDE official website, the new clinical trial application for Asciminib, a BCR-ABL allosteric inhibitor submitted by Novartis (NVS.US), has been tacitly approved (acceptance number: JXHL2300178) for the treatment of patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).

It is reported that Asciminib was granted accelerated approval by the FDA in October 2021 for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received at least two prior TKI treatments, and full approval for adult patients with T315I mutation-positive Ph+ CML-CP. Subsequently, it was approved for marketing in Japan and the European Union in March and August 2022, respectively.

In China, clinical trials for chronic myeloid leukemia were first launched in March 2021. Currently, four clinical trials are being conducted, including a Phase I/II clinical trial (Registration No.: NCT04925479) that was registered and initiated on the ClincalTrials.gov platform on October 4, but has not yet been registered and initiated on the CDE clinical trial platform. Among these, the Phase III clinical trial (Registration No.: NCT04971226) has completed the recruitment of all participants. This study aims to compare the clinical efficacy of Asciminib and TKI therapy in newly diagnosed Ph+ CML-CP patients.