Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) have received U.S. Food and Drug Administration supplemental New Drug approval for Nexavar (sorafenib).
Nexavar is the first FDA approved drug indicated for the treatment of patients with liver cancer (unresectable hepatocellular carcinoma - HCC). It is an oral anticancer and has shown significant overall survival in patients since it was first used in 2005.
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The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of
liver cancer, and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease."
HCC is the most common form of liver cancer and is responsible for approximately 90 percent of the primary malignant tumors in adults. Liver cancer is the 6th most common cancer in the world and globally is the 3rd leading cause of cancer related deaths.
[Source: PRNewsWire]
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» Bayer from PharmaGazette
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