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The only FDA-approved systemic therapy for TGCT/PVNS/GCT-TS not amendable to improvement with surgery

Less Tumor. More Movement.

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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).1,2 Of 120 total patients, results were excluded for 32 with missing data.1

Discover the clinical data from ENLIVEN trial

ENLIVEN DATA

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Systemic therapy for TGCT

TURALIO is the first and only FDA-approved, NCCN category 1–recommended systemic therapy for TGCT, also known as PVNS or GCT-TS

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 400 mg orally
twice daily.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 400 mg orally
twice daily.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 400 mg orally twice daily.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 400 mg orally twice daily.1

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Pexidartinib is a category 1 recommendation* for TGCT/PVNS in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma2

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

TURALIO was approved in 2019 as the first systemic therapy for TGCT.1

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References: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2021. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 29, 2022. 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.