普納替尼（ponatinib）是一種多靶點(diǎn)的激酶抑制劑，已經(jīng)被美國和歐盟批準(zhǔn)用于治療慢性粒細(xì)胞白血病及費(fèi)城染色體陽性的急性淋巴細(xì)胞白血病。2013年10月31日，鑒于“危及生命的血栓和血管重度狹窄”風(fēng)險(xiǎn)，F(xiàn)DA要求生產(chǎn)商暫停其銷售和推廣，這也是首個(gè)被撤市的小分子激酶抑制劑類抗腫瘤藥。因普納替尼未來我國申請進(jìn)口，其撤市不會給我國造成直接影響，但會影響到其他在我國上市或正在研發(fā)的同類品種的市場銷售或上市進(jìn)度。因此，建議我國藥品監(jiān)管部門要加強(qiáng)激酶類小分子抗腫瘤藥的不良反應(yīng)事件的監(jiān)管，并及時(shí)將相關(guān)信息反饋給國內(nèi)相應(yīng)仿制藥企業(yè)。制藥企業(yè)在新藥上市前要進(jìn)行充分的安全性評價(jià)，盡早發(fā)現(xiàn)潛在的風(fēng)險(xiǎn)，以便采取有效措施避免損失。

Iclusig is an inhibitor of mutiple kinases indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph⁺ 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 This is also the first withdrawn small molecule kinase inhibitor of anticancer drugs.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.