+ ALL). On October 31, 2013, the U.S. Food and Drug Administration (FDA) has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels. This is also the first withdrawn small molecule kinase inhibitor of anticancer drugs. The withdrawal of ponatinib does not directly affect Chinese domestic drug market because it was not developed clinical studies and approved. But it will impact the marketing sale or progress of other molecule kinase inhibitor of anticancer drugs including approved and pipeline drugs. Therefore, we suggest that the drug supervision departments should strengthen the monitoring of post-approval drug safety, including small molecule kinase inhibitor of anticancer drugs. The drug supervision departments should feedback drug adverse effects information timely to the relevant corresponding domestic generic drug companies. Pharmaceutical companies should conduct adequate drug safety assessment, early detect the potential risks before new drugs launch, in order to take effective measures to protect patients from drug risks."/>

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普納替尼撤市原因分析及對我國新藥研發(fā)的啟示

Cause analysis on withdrawal of ponatinib and its implication for drug development in China

發(fā)布日期:2014-01-25
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