AstraZeneca's Next-Gen BTK Inhibitor Acalabrutinib Receives China Approval for Relapsed/Refractory Mantle Cell Lymphoma

Intelligent Finance APP learned on March 22 that, according to the latest announcement by the National Medical Products Administration (NMPA), the BTK inhibitor acalabrutinib capsules (trade name: Kang Keqi) developed by AstraZeneca (AZN.US) have been approved for marketing in China. Acalabrutinib is one of the key products in AstraZeneca’s hematology pipeline and has previously received Priority Review, Breakthrough Therapy Designation, and Orphan Drug Designation from the U.S. FDA. Public information shows that this approval in China is for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Acalabrutinib is a new generation selective BTK inhibitor that can covalently bind to BTK and inhibit its activity. In B cells, BTK signaling leads to the activation of pathways required for B-cell proliferation, trafficking, chemotaxis, and adhesion.

MCL is a rare type of non-Hodgkin lymphoma (NHL) that is typically aggressive in clinical presentation. According to publicly available data from AstraZeneca, the approval of acalabrutinib for the MCL indication in China was primarily based on the global clinical study ACE-LY-004 involving adult MCL patients who had received at least one prior treatment, as well as the results from a Chinese phase 1/2 clinical study targeting MCL and other B-cell malignancies in patients who had received at least one prior treatment. The standard approval of this indication will depend on the results of ongoing confirmatory randomized controlled clinical trials.