WASHINGTON, Aug. 2 (Xinhua) -- The U.S. Food and Drug Administration (FDA) granted on Friday its first approval for treatment of adult patients with a rare joint tumor.
Turalio capsule was approved for treating the symptomatic tenosynovial giant cell tumor (TGCT) that is not responsive to improvement with surgery, according to the FDA.
TGCT is a rare tumor that affects the tendon sheaths and the thin layer of tissue that covers the surfaces of the joint spaces. It is rarely malignant but can cause severe disability and functional limitations.
"Surgery is the primary treatment option, but some patients are not eligible for surgery, and tumors can recur, even after the procedure," said Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Today's approval is the first FDA-approved therapy to treat this rare disease."
In an international clinical trial, patients who received Turalio demonstrated a statistically significant improvement in overall response rate (38 percent). Those who received placebo had no responses.
Also, 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, according to the FDA.
