Drug approved to treat tenosynovial giant cell tumor

Drug approved to treat tenosynovial giant cell tumor

(HealthDay)—Turalio (pexidartinib) capsules have been approved to treat adults with symptomatic tenosynovial giant cell tumor (TGCT), the U.S. Food and Drug Administration announced.

The drug was approved for patients with TGCT with severe morbidity or functional limitations that has not improved with surgery. Turalio is only available through the Risk Evaluation and Mitigation Strategy Program.

Approval was based on data from a multicenter international clinical trial of 120 patients. After 25 weeks, patients who received Turalio had a statistically significant improvement in overall response rate (ORR) to an ORR of 38 percent versus no response in patients who received placebo. Fifteen percent of patients had a complete response and 23 percent had a partial response. Among patients followed for a minimum of six months following initial response, 22 of 23 patients maintained their response for six months or longer; all 13 patients who initially responded and were followed for a minimum of 12 months maintained their response for 12 months or longer.

Commonly reported include lactate dehydrogenase, increased aspartate aminotransferase, loss of hair color, increased , and increased cholesterol. Side effects also include neutropenia, increased , decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate. A Boxed Warning on the for Turalio warns about the risk for serious and potentially fatal liver injury and advises to monitor patients' liver tests before and during treatment and to alter or discontinue use of the drug if liver tests are abnormal.

Approval was granted to Daiichi Sankyo.


Explore further

Xpovio with dexamethasone approved for refractory multiple myeloma

More information: More Information

Health News Copyright © 2019 HealthDay. All rights reserved.

Citation: Drug approved to treat tenosynovial giant cell tumor (2019, August 5) retrieved 25 August 2019 from https://medicalxpress.com/news/2019-08-drug-tenosynovial-giant-cell-tumor.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
3 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more