Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma
Across two clinical trials 82% overall response and 35% complete response rate were observed in Chinese patients using Calquence.AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This is the first approved indication for Calquence in China. The conditional approval by the National Medical Products Administration (NMPA) was based on positive results from two clinical trials,