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Bayer/Onyx sorafenib accepted into Pilot 1

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bayer/Onyx' oncologic sorafenib (formerly BAY 43-9006) is accepted into FDA's continuous marketing application Pilot 1 program, the firms announce May 4. The acceptance pertains to the dual RAF kinase/VEGF inhibitor's use in renal cell carcinoma. Bayer/Onyx said an NDA is "in the preparation stages"; the sponsors continue to project a first-half 2006 approval for metastatic RCC. A separate Phase III clinical program in hepatocellular carcinoma began in March (1Pharmaceutical Approvals Monthly March 2005, In Brief)...

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