FGFR inhibitor is qualified for FDA's prior approval
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Last Update: 2019-12-03
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Source: Internet
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Author: User
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News events Today, Incyte announced that FDA has accepted the listing application of its FGFR inhibitor, pemigatinib, for the second-line treatment of advanced cholangiocarcinoma after FGFR2 fusion or translocation In a phase II clinical trial called light-202, pemigatinib produced a 36% response rate and a median response time of 7.5 months in this population The FDA gives pemigatinib the priority approval qualification, which is usually a priority approval channel to significantly improve the treatment of new drugs without standard therapy, which is 4 months shorter than the standard approval time The PDUFA date for this product is May 30 next year Drug source analysis
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