FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

FDA Approves Turalio for Treating TGCT

Aug. 6, 2019
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Daiichi Sankyo’s Turalio (pexidartinib) has received FDA approval for treating tenosynovial giant cell tumor (TGCT), a group of rare, debilitating benign tumors.

The approval makes the medicine the first to be approved by FDA for treating the rare disease, which can cause pain and stiffness and hinder a patient’s movement. Although surgery is usually chosen for treating the disease, some patients aren’t eligible for surgery, and in some cases tumors can recur even after the procedure.

Turalio comes with a boxed warning to alert patients and healthcare providers to the drug’s risk of serious and potentially fatal liver injury.

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