Calquence approved in China for chronic lymphocytic leukaemia
AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy
The approval by the National Medical Products Administration (NMPA) was based on positive results from two clinical trials, including the ASCEND Phase III trial of Calquence versus investigator’s choice of idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) for patients with relapsed or refractory (R/R) CLL and an open-label, single-arm Phase I/II trial in China for patients with R/R CLL. CLL is the most prevalent type of adult leukaemia across the globe and represents approximately 6.4% of B-cell non-Hodgkin lymphoma patients in China.
Professor Li Jianyong, Director of Haematology, People’s Hospital of Jiangsu Province, and Leader of China CLL Working Group, said: “Many people living with chronic lymphocytic leukaemia experience relapse and need additional treatment options to help manage their disease. I’m delighted that with this approval patients now have access to an established treatment that has already demonstrated effectiveness in many patients across the globe.”
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