AstraZeneca said its Calquence product has been approved in China for the treatment of adults with leukaemia.
The Anglo-Swedish pharma giant said Monday the product has been approved for the treatment of patients with chronic lymphocytic leukaemia, or CLL--the most prevalent type of leukaemia across the globe--or small lymphocytic lymphoma, or SLL, assuming they have received at least one prior therapy.
The approval by the National Medical Products Administration was based on positive results from two clinical trials, one global and one local. The latter trial showed an 83.3% overall response rate in Chinese patients treated with Calquence.
Calquence is approved for the treatment of CLL and SLL in the U.S., CLL in the European Union and other countries around the world, and approved in Japan for relapsed CLL and SLL.
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