Liver tox cases force Daiichi Sankyo to curtail recruitment for PhIII trial of a ‘breakthrough’ drug
Two cases of serious liver toxicity forced investigators to suspend enrollment on Daiichi Sankyo’s Phase III program for its “breakthrough” drug pexidartinib (PLX3397). But both cases were non-fatal, a company spokesperson tells Endpoints News, and the trial is headed to completion after the company decided to wrap enrollment a few subjects short of their goal.
Daiichi Sankyo is testing the drug on rare cases of tenosynovial giant cell tumor (TGCT) among patients who couldn’t qualify for surgical removal of the tumor. By the time the liver tox issues appeared, the company had already enrolled 121 of the planned 126 patients and the data monitoring committee suggested cutting enrollment short and taking measures so they could preserve the study as a double-blinded test.
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