Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant of imatinib mesylate (Glivec).
CML, characterized by the abnormal proliferation of hematopoietic stem cells in the bone marrow, is the most prevalent form of chronic leukemia, representing approximately 15% of all leukemia cases. While imatinib, the first-generation TKI, has improved the 10-year survival rate to about 85%, nearly 30% of patients experience resistance and genetic mutations that diminish its effectiveness.
Dasatinib, initially co-developed by BMS and AstraZeneca, was first approved in China in September 2011. Subsequent generic versions were introduced by Sino Bio and CSPC in 2013 and 2020, respectively. Dasatinib continues to be recommended by various treatment guidelines in China and internationally for both first and second-line CML therapy.- Flcube.com
