FDA Panel Backs Pexidartinib for Tenosynovial Giant Cell Tumor

May 14, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 3 in favor of pexidartinib for an indication as a treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT). Under the Prescription Drug User Fee Act, the FDA will now make a decision on the pexidartinib indication by August 3, 2019. A priority review designation was initially granted to the application for the investigational, small molecule, CSF1R inhibitor in February … (leggi tutto)