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FDA Grants Priority Review to Pexidartinib for Tenosynovial Giant Cell Tumor

Gina Columbus @ginacolumbusonc
Published: Tuesday, Feb 05, 2019

The FDA has granted a priority review designation to a new drug application (NDA) for the investigational, small molecule, CSF1R receptor inhibitor pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT).1

ASCO made the announcement as part of Clinical Cancer Advances 2019: ASCO’s Annual Report on Progress Against Cancer, an annual update that highlights the most impactful clinical research milestones and policy developments that have been achieved over the past year in oncology.


  1. 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. Daiichi Sankyo. Published February 5, 2019. Accessed February 5, 2019.
  2. Tap WD, Gelderblom H, Stacchiotti S, et al. Final results of ENLIVEN: A global, double-blind, randomized, placebo-controlled, phase 3 study of pexidartinib in advanced tenosynovial giant cell tumor (TGCT). J Clin Oncol. 2018;36 (suppl; abstr 11502). doi: 10.1200/JCO.2018.36.15_suppl.11502.
  3. Pal SK, Miller MJ, Agarwal N, et al. Clinical Cancer Advances 2019: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology [published online ahead of print]. J Clin Oncol. doi: 10.1200/JCO.18.02037.

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