Shots:

• The first patient has been dosed in a P-II two-part OLE study that assesses the safety- efficacy- and PK of Pexidartinib {800mg/day (400mg- bid on an empty stomach)} in ~18 patients with symptomatic TGCT associated with severe morbidity or functional limitation and not amenable to improvement with surgery
• The 1EP of the study is dose-limiting toxicity and analysis of PK and ORR as assessed by RECIST Version 1.1. The 2EPs include ORR by tumor volume score- range of motion- PRO and treatment-emergent AEs
• Pexidartinib is a small molecule that inhibits CSF-1R (colony-stimulating factor-1 receptor)- KIT and FLT3-ITD- currently being evaluated for TGCT in Japan- Taiwan and China

  Ref: Daiichi Sankyo | Image: Pharma Diversity Job Board