Daiichi Sankyo’s Turalio (pexidartinib) Receives the US FDA’s Approval for the Symptomatic Tenosynovial Giant Cell Tumor

Daiichi Sankyo’s Turalio (pexidartinib) Receives the US FDA’s Approval for the Symptomatic Tenosynovial Giant Cell Tumor

Shots:

  • The FDA’s approval is based on P-III ENLIVEN study results assessing Turalio vs PBO in 120 patients in ratio (1:1) with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
  • The P-III ENLIVEN study results: @25wks. tumor response rate by RECIST v 1.1 (38% vs 0%); ORR by TVS (56% vs 0%). Turalio is approved with a boxed warning for hepatotoxicity due to the risk of liver injury
  • Turalio is first oral therapy targeting CSF1R thus inhibiting the driver of abnormal cells in the synovium responsible for causing TGCT and has received FDA’s PR, BT, OD designation, currently under EMA’s review for TGCT

Click here to­ read full press release/ article | Ref: Daiichi Sankyo | Image: ET Health world