Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

 Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

Daiichi Sankyo Initiates P-II Trial of Pexidartinib for Tenosynovial Giant Cell Tumor in Japan

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

Click here to­ read full press release/ article | Ref: Daiichi Sankyo | Image: Pharma Diversity Job Board

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