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Renal Cell Carcinoma

U.S. FDA grants orphan drug designation to BAY 43-9006

Published in Cancer Weekly, November 23rd, 2004

Bayer Pharmaceuticals Corp. (BAY) and Onyx Pharmaceuticals, Inc., (ONXX) announced that sorafenib (BAY 43-9006) has been granted orphan drug status for the treatment of renal cell carcinoma by the U.S. Food and Drug Administration (FDA).

The compound is being evaluated for the treatment of metastatic renal cell carcinoma, an advanced form of kidney cancer. A similar designation has been granted in the European Union by the committee for Orphan Medicinal Products of the European Medicines Agency.

Currently in phase III clinical testing, BAY 43-9006 is a novel RAF kinase and VEGFR inhibitor that is intended to prevent tumor growth by combining two...

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