FDA accepts new drug application from Incyte's FGFR1/2/3 inhibitor pemigatinib
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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today, incyte(http:// announcedthat the U.SFDA(http://has accepted its FGFR1/2/3 inhibitor pemigatinibnew drug(http://application (NDA) for the treatment of patients with late-stage or metastatic treatment of hepatic endocostoic heyeropathic (iCCA) patients with FGFR2 gene fusion or rearrangementPemigatinib is an oral small molecule inhibitor targeted at FGFR1, 2 and 3, and its preclinical data demonstrate excellent efficacy and safety for tumors with The FGFR gene mutationbefore that, the FDA had granted pemigatinib a breakthrough treatment for bile duct cancer and the eligibility of orphan drugsThe NDA submission is based on data on the effectiveness and safety of patients treated with pre-local advanced or metastatic hepatic biliary cancer in a phase 2trial(http://) called FIGHT-202results showed that in subgroups of patients carrying FGFR2 gene fusion or rearrangement, pemigatinib's monotherapy achieved an objective remission rate (ORR) of 36% and median remission time (DOR) of 7.5 months
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