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Defining REMS Success An Unanswered Question For Daiichi's Pexidartinib

 
• By Derrick Gingery

US FDA still deliberating on how best to measure success of the liver safety program for Daiichi's TGCT treatment, but REMS will probably assess both process and outcomes. 

Liver cancer, CT scan upper abdomen.
FDA wants to collect long-term data on pexidartinib's liver toxicity risks as part of a Risk Evaluation and Mitigation Strategy. • Source: Shutterstock

The US Food and Drug Administration has yet to determine what would constitute successful risk management for Daiichi Sankyo Co. Ltd.'s proposed rare cancer treatment pexidartinib.

Pexidartinib is proposed for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

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