Monday, September 04, 2023
AstraZeneca has announced the approval of Calquence (acalabrutinib), a next-generation selective Bruton's tyrosine kinase (BTK) inhibitor, in China. This approval is for treating adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in China who have received at least one prior treatment.
This approval from the National Medical Products Administration (NMPA) was granted based on positive results from two clinical trials. The first trial was the ASCEND Phase III trial, which compared Calquence to the investigator's choice of idelalisib plus rituximab (IdR) or bendamustine plus rituximab (BR) for patients with relapsed or refractory (R/R) CLL. The second trial was an open-label, single-arm Phase I/II trial conducted in China for patients with R/R CLL.
Calquence has already been approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the United States and Japan. It is also approved for the treatment of CLL in the European Union and in several other countries globally, both in the treatment- naïvoe and relapsed or refractory (R/R) settings.
Additionally, Calquence is approved in the United States, China, and several other countries for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Many individuals living with chronic lymphocytic leukaemia experience relapse and require additional treatment options to effectively manage the disease. With this approval, patients in China now have access to a well-established treatment that has already demonstrated its effectiveness in numerous patients worldwide.