New drug application for the first three CSF1R inhibitors pexidartinib is eligible for FDA Priority Review
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Daiichi Sankyocompany(http://announced that its application for theofNew Drug (http://(NDA) for the CSF1R inhibitor pexitinib has been accepted by the u.SFDA(http://, and the FDA has granted the application a priority reviewPexidartinib is used to treat tendon cytoblastoma (TGCT), a rare deactivation tumorIf approved, pexidartinib will be the first and only approved treatment for TGCTAbout Pexidartinib
Pexidartinib is an innovative oral small molecule CSF1R inhibitorThe CSF1R-mediated signaling pathway is the main factor driving abnormal cell proliferation in the slip membrane, which causes the production of TGCTPexidartinib has been awarded the FDA's ground-breaking therapeutic designation and orphan drug eligibilitythe new drug application is based on the performance of pexidartinib in a phase 3 clinicaltrial(http://called ENLIVEN, in which 120 TGCT patients were treated with a randomized double-blind, multicenter critical Phase 3 clinical trial, which may have a worse effect on functional function if performedresults showed that the main endpoint of the test was achieved, significantly reducing the size of the tumor compared to the control group
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