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Bayer/Onyx 43-9006 in Phase III for HCC

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bayer/Onyx are starting a Phase III study of their oral RAF kinase/VEGF inhibitor 43-9006 (sorafenib) for use as monotherapy in advanced hepatocellular carcinoma, the firms say March 8. Five hundred patients without prior systemic treatment will be randomized in the double-blind, placebo-controlled trial; overall survival, time to symptom progression and time to tumor progression will be assessed. Median survival was 9.2 months and median time to progression was 4.2 months in a Phase II HCC trial. Bayer/Onyx originally planned to submit 43-9006 for renal cell carcinoma based on Phase II data, but are now waiting for results from an 800-patient Phase III study (1Pharmaceutical Approvals Monthly November 2004, p. 35). Both Phase III trials received special protocol assessments from FDA...

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