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

Oct 13, 2023 06:30 CST Updated 06:30

Novartis

Drug Development and Manufacturing

On October 12, according to the CDE official website, Novartis submittedThe new clinical trial application for BCR-ABL allosteric inhibitor Asciminib has been granted tacit approval (Application No.: JXHL2300178).Used forTreatment of patients with chronic myeloid leukemia (CML); patients with acute lymphoblastic leukemia (ALL).

Source: CDE Official Website

Asciminib Developed by NovartisOneSpecies-specific targetingBCR-ABL1 Protein MeatMyristoyl Pocket (STAMP）Inhibitor, by combining ABLMyristoyl pocket plays a role.

According to the Insight database, Asciminib received accelerated FDA approval in October 2021 for use in adult patients with Philadelphia chromosome-positive CML in the chronic phase (Ph+ CML-CP) who have been previously treated with at least two TKIs. It also received full approval for adult patients with T315I mutation-positive Ph+ CML-CP. Subsequently, it was approved for marketing in Japan and the EU in March and August 2022, respectively.

In China, clinical trials were first initiated in March 2021 for chronic myeloid leukemia. Currently, four clinical trials are underway, including a Phase I/II clinical trial (Registration No.: NCT04925479) registered on the ClincalTrials.gov platform on October 4. This trial has not yet been registered on the CDE clinical trial platform.

Among them, the Phase III clinical trial (Registration No.: NCT04971226) has completed the recruitment of all subjects. This study aims to compare the clinical efficacy of Asciminib and TKI therapy in newly diagnosed Ph+ CML-CP patients.

Asciminib Clinical Trials Conducted in China

Source: Insight Database Web Version