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Pexidartinib Approval Status

FDA Approved: No (Pending Approval)
Generic name: pexidartinib
Company: Daiichi Sankyo
Treatment for: Tenosynovial Giant Cell Tumor

Pexidartinib is a CSF1R (colony stimulating factor-1 receptor) inhibitor in development for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).

Development Status and FDA Approval Process for pexidartinib

DateArticle
May 14, 2019FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo’s Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor
Feb  5, 2019FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor
Jun  4, 2018Daiichi Sankyo Presents Phase 3 ENLIVEN Study of Pexidartinib, Demonstrating Statistically Significant Clinical Improvement Across Multiple Endpoints in Patients with Tenosynovial Giant Cell Tumor
Oct 21, 2016ENLIVEN Phase 3 Study of Pexidartinib in Tenosynovial Giant Cell Tumor (TGCT) Will Continue to Completion Following Enrollment Discontinuation
Oct 30, 2015FDA Grants Breakthrough Therapy Designation for Daiichi Sankyo and Plexxikon’s Investigational CSF-1R Inhibitor Pexidartinib (PLX3397) in Tenosynovial Giant Cell Tumor

Further information

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