Clinical trial design

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TURALIO: the first FDA-approved, oral systemic therapy for symptomatic TGCT with proven efficacy and safety in an international, phase 3, placebo-controlled trial1-3

The ENLIVEN trial focused on patients with histologically confirmed, advanced, symptomatic TGCT1,2

  • Surgical removal of the tumor would be associated with worsening of functional limitations or severe morbidity
  • Measurable tumor size of ≥2 cm by RECIST v1.1
     	The ENLIVEN trial focused on patients with histologically confirmed advanced, symptomatic TGCT Chart describing primary and secondary endpoints with TURALIO      	The ENLIVEN trial focused on patients with histologically confirmed advanced, symptomatic TGCT Chart describing primary and secondary endpoints with TURALIO

ENLIVEN excluded patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5x upper limit of normal (ULN), and patients with known active or chronic infection with hepatitis B or C virus or human immunodeficiency virus.1

aSecondary endpoints were assessed at week 25, except DOR.2

bTVS was defined in ENLIVEN as the estimated volume of the maximally distended synovial cavity or tendon sheath involved, measured in 10% increments.1

TURALIO was studied in patients with and without prior surgery with symptomatic TGCT for whom surgical removal of the tumor would be associated with worsening functional limitations or severe morbidity.1,3

TURALIO was studied in patients with and without prior surgery with symptomatic TGCT TURALIO was studied in patients with and without prior surgery with symptomatic TGCT

Other baseline characteristics of patients in the ENLIVEN trial: The median age was 44 years (range: 18-79); 59% of patients were females; 88% of patients were White. Disease locations were knee (61%), ankle (18%), hip (11%), wrist (3%), foot (3%), and other (5%).

Discover the clinical data from the ENLIVEN trial
ENLIVEN DATA

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References: 1. TURALIO [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2025. 2. Tap WD et al; ENLIVEN investigators. Lancet. 2019;394(10197):478-487. 3. 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