(RTTNews) - China's National Medical Products Administration approved AstraZeneca plc.'s (AZN, AZN.L) Calquence or acalabrutinib for the treatment of adult patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least one prior therapy. Calquence is a next generation, selective Bruton's tyrosine kinase (BTK) inhibitor.
The approval was based on results from ASCEND global phase III trial and a phase I/II local trial, which showed 83.3% overall response rate in Chinese patients treated with Calquence.
Chronic lymphocytic leukaemia 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.
Calquence is approved for the treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma in the US and Japan and is approved for the treatment of chronic lymphocytic leukaemia in the EU and in several other countries worldwide in the treatment-naïve and relapsed or refractory settings.
Calquence is also approved in the US, China and several other countries for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. Calquence is not currently approved for the treatment of mantle cell lymphoma in Japan or the EU.
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