Turalio Approval History
FDA Approved: Yes (First approved August 2, 2019)
Brand name: Turalio
Generic name: pexidartinib
Dosage form: Capsules
Company: Daiichi Sankyo
Treatment for: Tenosynovial Giant Cell Tumor
Turalio (pexidartinib) is a kinase inhibitor indicated for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adults.
Development History and FDA Approval Process for Turalio
|Aug 2, 2019|| FDA Approves Turalio (pexidartinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumors (TGCT) in Adults|
|May 14, 2019||FDA 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, 2019||FDA 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, 2018||Daiichi 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, 2016||ENLIVEN Phase 3 Study of Pexidartinib in Tenosynovial Giant Cell Tumor (TGCT) Will Continue to Completion Following Enrollment Discontinuation|
|Oct 30, 2015||FDA Grants Breakthrough Therapy Designation for Daiichi Sankyo and Plexxikon’s Investigational CSF-1R Inhibitor Pexidartinib (PLX3397) in Tenosynovial Giant Cell Tumor|
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