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Mechanism of action: Ibrutinib is a small molecule BTK inhibitor that binds covalently to the cysteine residue of the BTK active center, thereby inhibiting its activity. BTK stands for Bruton'styrosinekinase, which transmits signals in the BCR signaling pathway and cytokine receptor signaling pathway, and mediates B cell migration, chemotaxis, and adhesion. Preclinical studies have demonstrated that Ibrutinib can inhibit the proliferation and survival of malignant B cells.
Clinical trials: 111 patients who had received at least one treatment had a total response rate of 65.8% (complete response 17.1% + partial response 48.6%) after treatment with ibrutinib. The median duration of response was 17.5 months.
Supplement: Ibrutinib is the second new drug approved by the FDA's breakthrough drug channel (the first is obinutuzumab), and also enjoys two other FDA buffs and seven years of administrative protection after listing. Due to the addition of multiple accelerated buffs, the clinical trial of the drug appeared to be very simple, with only 111 patients enrolled, and the clinical endpoint was response rate rather than survival. Mantle cell lymphoma is a rare non-Hodgkin's lymphoma. The FDA previously approved bortezomib and lenalidomide in 2006 and 2013 to treat the disease. Ibrutinib is a key product that Johnson & Johnson bought from Pharmacyclics at a high price. In addition to treatment of mantle cell lymphoma, it is also used for chronic lymphocytic leukemia and small lymphocytic lymphoma.
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