FDA Approves Turalio (Pexidartinib) for TGCT

August 7, 2019

Kinase inhibitor oral capsules.

The FDA has approved kinase inhibitor pexidartinib (Turalio, Daiichi Sankyo) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. 

Pexidartinib is indicated at 400mg taken orally twice daily on an empty stomach at least 1 hour before or 2 hours after a meal or snack, available in 200mg tablets. 

According to a boxed warning, pexidartinib may cause serious and potentially fatal livery injury. Prescribing information instructs healthcare providers to monitor liver tests prior to pexidartinib and at specific intervals throughout treatment. 

Other warnings include the potential of embryo-fetal toxicity that may result in fetal harm. 

Pexidartinib is known to interact with hepatotoxic products, CYP3A inhibitors, strong CYP3A inducers, UGT inhibitors, and acid reducing agents. 

Adverse events reported throughout clinical trials of pexidartinib include increased lactate dehydrogenase, increased aspartate aminotransferase, hair color changes, fatigue, increased alanine aminotransferase, decreased neutrophils, increased cholesterol, increased alkaline phosphatase, decreased lymphocytes, eye edema, decreased hemoglobin, rash, dysgeusia, and decreased phosphate.

 

 

Full Prescribing Information