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US FDA panel seeks more data on Vion's leukaemia drug Onrigin

This article was originally published in Scrip

Executive Summary

Citing pulmonary safety concerns and questions about efficacy, the US FDA's oncologic drugs advisory committee unanimously concluded that a randomised controlled trial is required before Vion Pharmaceuticals's Onrigin (laromustine) can be approved for elderly patients with acute myeloid leukaemia (AML).

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