FDA accepts and grants priority review of new drug application for first-third-in-a-nation pexidartinib

recently, Daiichi Sankyo, a Japanese pharmaceutical company, announced that the u.SFood andDrug(http://Administration (
FDA(http://) had accepted thenew drug(http://application for pexidartinib and granted priority examination qualification (PRD)the NDA application approved for the treatment of adult patients with severe morbidity or functional limitations who are not suitable for surgical improvement of symptomatic tendoncytoma (TGCT)About pexidartinib
pexidartinib is an experimental, new oral small molecule that effectively inhibits the concentration-stimulator-1 receptor (CSF1R)CSF1R is the main growth driver for abnormal cells in tGCT's sliding membranepexidatinib can also suppress c-kit and FLT3-ITDpexidatinib, led by the first three-year-old small molecular structure-directing research and development center Plexxikon(http://found that the drug is the second compound in the first three-way pipeline to be accepted by the FDA in less than four months, which will help advance the company's mission to submit seven different new cancer molecular entities by 2025in addition to priority review eligibility, the FDA also granted pexidartinib treatment TGCT breakthrough drug eligibility, orphan drug eligibilityIn Europe, pexidartinib has also been granted an orphan drug for the treatment of TGCTCurrently, there is no systematic therapy for TGCTIf approved, pexidartinib will be the first and only drug to be approved for the treatment of asymptomatic TGCT, which has severe morbidity or functional limitations and is not suitable for surgical improvement