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

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