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# Turalio Approved for Tenosynovial Giant Cell Tumor
- URL: https://www.fdaweb.com/turalio-approved-for-tenosynovial-giant-cell-tumor/
- Published: 2019-08-02T12:00:00.000Z
- Updated: 2026-09-15T01:41:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144682

FDA has approved a Daiichi Sankyo NDA for Turalio (pexidartinib) capsules for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. TGCT is a rare tumor that affects the synovium (thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths (layer of membrane that covers tendons), an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-rare-joint-tumor?ref=fdaweb.com) says. “The tumor is rarely malignant but causes the synovium and tendon sheaths to thicken and overgrow, causing damage to surrounding tissue,” it says.

Approval was based on data from an international clinical trial involving 120 patients, 59 of whom received placebo. The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. “The clinical trial demonstrated a statistically significant improvement in ORR in patients who received Turalio, with an ORR of 38%, compared to no responses in patients who received placebo,” FDA says. “The complete response rate was 15% and the partial response rate was 23%. A total of 22 out of 23 responders who had been followed for a minimum of six months following the initial response maintained their response for six or more months, and a total of 13 out of 13 responders who had been followed for a minimum of 12 months following the initial response maintained their response for 12 or more months.”