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
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