Daiichi suspends pexidartinib trial on liver worries

Daiichi Sankyo Co. Ltd. (Tokyo:4568) suspended enrollment in the Phase III ENLIVEN trial of pexidartinib ( PLX3397) to treat symptomatic tenosynovial giant cell tumor (TGCT). A data monitoring committee recommended the suspension after reviewing two reports of non-fatal liver toxicity in ENLIVEN, spokesperson Jennifer Brennan told BioCentury.

At the time of suspension, 121 of a planned 126 patients had been enrolled. Brennan said FDA has agreed to additional measures to address safety concerns and will allow the company to continue the study to completion. Brennan was uncertain when Daiichi expects final ENLIVEN results. ...