Xinhua News Agency, Beijing (Reporter Zhang Zhaohui) — On August 13, the official website of the National Medical Products Administration announced that Qilu Pharmaceutical's anti-tumor drug Dasatinib Tablets (Youdafar) has been approved for marketing, offering a new medication option for patients with chronic leukemia. This approval for Youdafar is considered as passing the consistency evaluation.
Dasatinib is used to treat adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, accelerated phase, and blast phase (myeloid and lymphoid blast crisis) who are resistant or intolerant to imatinib mesylate.
Chronic Myeloid Leukemia (also known as Chronic Myelogenous Leukemia) is a malignant tumor formed by the abnormal proliferation of hematopoietic stem cells in the bone marrow. It is the most common type of chronic leukemia, accounting for approximately 15% of all leukemia patients. Although the first-generation TKI drug Imatinib Mesylate has increased the 10-year survival rate of patients to about 85%, nearly 30% of patients still experience drug resistance and genetic mutations leading to loss of efficacy. Second-generation TKI drugs have stronger inhibitory effects on cell proliferation and kinase activity compared to Imatinib, and can induce faster and deeper disease remission.
Dasatinib, as a second-generation TKI, is a dual kinase inhibitor of BCR-ABL tyrosine kinase and SRC family kinases. By blocking the activity of abnormal tyrosine kinases, it inhibits the growth and proliferation of leukemia cells. Due to its good efficacy and tolerability in clinical practice, dasatinib has been recommended by multiple authoritative guidelines both in and outside China as a first-line and second-line treatment for chronic myeloid leukemia (CML). It is suitable for CML patients at all stages, including elderly patients, those with a history of cardiovascular or cerebrovascular diseases, abnormal glucose and lipid metabolism, or impaired liver function.
Proofread by Wang Xin