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TURALIO® Final Long-Term Data Showed Sustained Clinical Benefit in Patients with Tenosynovial Giant Cell Tumor from Open-Label Extension of ENLIVEN Phase 3 Trial
BASKING RIDGE, N.J., July 09, 2025--Final long-term efficacy and safety results from the open-label extension of the ENLIVEN phase 3 trial showed a sustained clinical benefit from long-term treatment with TURALIO® (pexidartinib) in patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to improvement with surgery. These results, consistent with the primary analysis of the trial, were recently published in The Oncologist.
About this update from Daiichi Sankyo Company, Limited
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":474,"url":"https://media.zenfs.com/en/business-wire.com/5127de5f417da01fecdb59119bedfbda"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/5s9SIR0lQc3mAzZHllN1og--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTk0ODtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/5127de5f417da01fecdb59119bedfbda","width":480,"height":474}},"lazy":false},{"type":"text","content":"BASKING RIDGE, N.J., July 09, 2025--(BUSINESS WIRE)--Final long-term efficacy and safety results from the open-label extension of the ENLIVEN phase 3 trial showed a sustained clinical benefit from long-term treatment with TURALIO® (pexidartinib) in patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to improvement with surgery. These results, consistent with the primary analysis of the trial, were recently published in The Oncologist.","length":462,"tagName":"p"},{"type":"text","content":"TURALIO is the first oral systemic therapy approved in the U.S. for adult patients with TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TGCT is a rare and typically non-malignant tumor that affects small and large joints.1,2,3","length":288,"tagName":"p"},{"type":"text","content":""Prior to the approval of TURALIO, the first FDA-approved systemic therapy for TGCT, there were limited treatment options beyond additional surgery," said Andrew Wagner, MD, PhD, medical oncologist, Dana-Farber Cancer Institute and Harvard Medical School. "The final results of the ENLIVEN trial show the potential for long-term tumor responses with TURALIO treatment with a safety profile consistent with earlier findings."","length":444,"tagName":"p"},{"type":"text","content":"Approval of TURALIO was based on results from the first part of the ENLIVEN phase 3 trial where 120 patients with advanced TGCT not amenable for surgery were randomized to TURALIO (n=61) or placebo (n=59). Efficacy outcomes were measured by overall response rate (ORR) by RECIST version 1.1, ORR by tumor volume score (TVS) and mean change in baseline in range of motion of the affected joint at Week 25. Study results from the first part of ENLIVEN showed an ORR of 38% (95% confidence interval [CI]: ...