FDA Approved: Turalio | First Therapy | TGCT Tumors

Turalio FDA Approval for Tenosynovial Giant Cell Tumor (TGCT) Treatment

Image: Turalio FDA approval

The U.S. Food and Drug Administration has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations, and not responsive to improvement with surgery. Turalio is available in 200mg tablets, with a recommended dose of 400mg taken orally twice daily on an empty stomach, at least 1 hour before or 2 hours after a meal or snack.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is a rare tumor that affects the synovium (the thin layer of tissue that covers the surfaces of the joint spaces) and tendon sheaths (the membrane that covers tendons, which connect muscle to bone). Although rarely malignant, TGCT causes the synovium and tendon sheaths to thicken and overgrow, leading to damage to the surrounding tissue.

Turalio FDA Designations

The FDA granted this application Breakthrough Therapy and Priority Review designations. Turalio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Warnings and Precautions

The prescribing information for Turalio includes a Boxed Warning about the risk of serious and potentially fatal liver injury. Health care professionals should monitor liver tests before and during treatment. If liver tests become abnormal, Turalio may need to be withheld, the dose reduced, or treatment permanently discontinued, depending on the severity of the liver injury.

Turalio is available only through the Turalio Risk Evaluation and Mitigation Strategy (REMS) Program to ensure its safe use.

Source: FDA, Daiichi Sankyo