CDE agrees to approve the listing of apatinib
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Last Update: 2014-10-08
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Source: Internet
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Author: User
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Apatinib is a small molecule tyrosine kinase inhibitor independently developed by Hengrui medicine It can selectively inhibit the tyrosine kinase activity of vascular endothelial growth factor receptor-2 (VEGFR-2), thus inhibiting tumor angiogenesis and tumor growth It is intended to be used in "the treatment of advanced gastric cancer with failure of second-line chemotherapy" clinically The report points out that in the randomized double-blind, placebo-controlled phase II and phase III trials, it has been observed that apatinib, as the third-line and above treatment, can prolong the survival of about 2 months compared with placebo, which has a positive clinical significance for the population with a survival time of 3-6 months Previous approved first-line and second-line chemotherapy and targeted drugs are mostly based on the survival advantage of prolonging about 2 months The main adverse reactions observed in clinical research are common adverse reactions of the same kind of anti angiogenic drugs, including hypertension, proteinuria, hand foot syndrome, etc serious adverse events such as hemorrhage, perforation, intestinal obstruction are rare, which belong to the predictable mechanism of action of this kind of drugs and can be controlled It is worth mentioning that apatinib has been submitted to CFDA for signature and is expected to be approved within one month according to the new drug review process.
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