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The first FDA-approved systemic therapy for symptomatic TGCT (also known as
PVNS or GCT-TS) associated with severe morbidity or functional
limitations and not amenable to improvement with surgery1,2

The first FDA-approved systemic therapy for symptomatic TGCT (also known as PVNS or GCT-TS) associated with severe morbidity or functional limitations and not amenable to improvement with surgery1,2

Less Tumor.
More Movement.

Less tumor: 38% overall response rate (ORR) at week 25 per RECIST (n=23 of 61; 95% CI: 27%, 50%)1

More movement: Significant improvement in mean change from baseline in range of motion (ROM) at week 25 with TURALIO (n=45) vs placebo (n=43; P=0.004). Of 120 total patients, results were excluded for 32 with missing data.1,3

Discover the clinical data from ENLIVEN trial

ENLIVEN DATA

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TURALIO is for adults with TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Systemic therapy for TGCT

Pexidartinib is the first FDA-approved, NCCN Category 1-recommended systemic therapy option for TGCT, also known as PVNS or GCT-TS1-41,2,4,5

In a clinical trial of 120 patients with advanced TGCT for whom surgery was not recommended, patients were randomized to placebo (n=59) or TURALIO (n=61) 1000 mg daily for 2 weeks followed by 400 mg twice daily. The efficacy outcomes measured at week 25 were ORR per RECIST v1.1, ORR per Tumor Volume Score (TVS), and mean change from baseline in ROM of the affected joint. The FDA-approved dose is 250 mg orally twice daily with a low-fat meal.1

In a clinical trial of 120 patients with advanced TGCT for whom surgery was not recommended, patients were randomized to placebo (n=59) or TURALIO (n=61) 1000 mg daily for 2 weeks followed by 400 mg twice daily. The efficacy outcomes measured at week 25 were ORR per RECIST v1.1, ORR per Tumor Volume Score (TVS), and mean change from baseline in ROM of the affected joint. The FDA-approved dose is 250 mg orally twice daily with a low-fat meal.1

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TURALIO is for adults with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Pexidartinib is a Category 1 recommended therapy option* for TGCT/PVNS in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma4

*A Category 1 recommendation indicates that, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.4

Dragonfly icon Dragonfly icon TURALIO is the first systemic therapy for TGCT approved by the FDA in 2019.2

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References: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2025. 2. FDA approves pexidartinib for tenosynovial giant cell tumor. U.S. Food & Drug Administration; August 8, 2019. Accessed January 3, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pexidartinib-tenosynovial-giant-cell-tumor 3. Tap WD et al; ENLIVEN investigators. Lancet. 2019;394(10197):478-487 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology [NCCN Guidelines® ] for Soft Tissue Sarcoma V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed January 7, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 5. Riedel RF et al. CancerCare. 2017:1-25. 431-2021_TGCT.pdf (cancercare.org). Accessed January 7, 2025.