AstraZeneca’s Calquence approved in China for chronic lymphocytic leukaemia treatment
AstraZeneca has announced that Calquence (acalabrutinib) has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) who have already had one prior therapy.
The National Medical Products Administration’s (NMPA) approval of this next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor follows positive results from two clinical trials, including the phase 3 ASCEND trial which compared the drug to idelalisib plus rituximab or bendamustine plus rituximab for the treatment of relapsed or refractory (R/R) CLL, and an additional phase 1/2 trial in china for patients with R/R CLL.
88% of patients in with R/R CLL in the ASCEND trial were alive and free from disease progression after 12 months, compared with 68% of patients in the standard of care treatment group.
Professor Li Jianuong, director of Haematology, People’s Hospital of Jiangsu Province, China and leader of China CLL Working Group, commented: “Many people living with CLL 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.”
Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, added: “Today’s approval is another step towards our goal of making Calquence available to as many patients as possible and offering physicians a treatment option with a well-established efficacy and tolerability profile. Patients with CLL are often older and dealing with significant comorbidities, and tolerability is a critical factor in their treatment.”
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