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Daiichi's Pexidartinib Likely Needs REMS For Liver Safety Concerns

 
• By Derrick Gingery

REMS with provider and pharmacy certification could help address hepatotoxicity worries for the tenosynovial giant cell tumor treatment, but Daiichi likely also will face clinical benefit questions during advisory committee review.

Cancer cells on scientific background.3d illustration
Daiichi Sankyo's pexidartinib showed a statistically significant improvement in overall response rate in TCGT patients compared to placebo. • Source: Shutterstock

Daiichi Sankyo Co. Ltd.'s proposed rare cancer treatment pexidartinib appears able to overcome its liver safety issues, but approval still may be hampered by questions about the clinical benefit the product provides.

Pexidartinib could be the first approved systemic therapy for treatment of tenosynovial giant cell tumor (TGCT). The product is proposed for adults with symptomatic TGCT associated with severe morbidity or functional limitations and is not amendable to improvement with surgery

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