Zanubrutinib granted approval for patients with R/R CLL/SLL and R/R MCL by China’s National Medical Products Administration

On June 3, 2020, China’s National Medical Products Administration (NMPA) granted approval for zanubrutinib, a Bruton tyrosine kinase inhibitor, in two indications — for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in adult patients who have received ≥ 1 prior therapies, and for the treatment of mantle cell lymphoma (MCL) in adult patients who have received ≥ 1 prior therapy.¹

This decision was based on data from the pivotal single-arm phase II study (NCT03206918) of zanubrutinib in patients with relapsed/refractory (R/R) CLL (n = 82) and R/R SLL (n = 9). The overall response rate was 62.6%, the complete response rate was 3.3%, the partial response (PR) rate was 59.3%, and the PR with lymphocytosis rate was 22%. The most common adverse events (AEs) were neutropenia, thrombocytopenia, hematuria, purpura, anemia, leukopenia, pneumonia, upper respiratory tract infection, hemorrhage, and rash. The incidence of any Grade ≥ 3 AE was 69.2%. The incidence of serious AEs was 19.8%, and the most common serious AE was pneumonia.

Approval of zanubrutinib in R/R MCL was based on results from a single-arm pivotal phase II study conducted in 86 patients in China (NCT03206970). The overall response rate was 83.7%, with a complete response rate of 68.6% and a PR rate of 15.1%. The most common AEs were neutropenia, rash, leukopenia, thrombocytopenia, and anemia. The incidence of serious AEs was 15.1%, and common serious AEs included pneumonia (8.1%), hemorrhage (2.3%), and thrombocytopenia (2.3%).

The U.S. Food and Drug Administration previously granted an accelerated approval to zanubrutinib for the treatment of adult patients with R/R MCL, click here to read more.