Daiichi Presses On With Lead Pexidartinib Trial Despite Liver Toxicity
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.
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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.
Oncology news and highlights from our US FDA Performance Tracker.
Daiichi Sankyo says it is “committed to a major transformation in oncology” as it prioritizes and pursues projects in this field under a new team leader, who chose to highlight unique antibody-drug conjugate technology and the acute myeloid leukemia franchise at a recent R&D Day in Tokyo.