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Daiichi Presses On With Lead Pexidartinib Trial Despite Liver Toxicity

 
• By Ian Haydock

Daiichi Sankyo is to continue with a multinational Phase III trial for its novel candidate for tenosynovial giant cell tumor despite cases of liver toxicity, but has stopped enrolment short of target and modified the protocol.

Daiichi Sankyo Co. Ltd. has halted enrollment just short of target in its multinational Phase III study with pexidartinib (PLX3397) for tenosynovial giant cell tumor (TGCT), following several reports of hepatic side effects.

The decision was taken on the recommendation of the ENLIVEN trial's data monitoring committee and followed two cases of serious but non-fatal liver toxicity

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