Onyx (ONXX), Bayer Win Early Approval for Colorectal Cancer Treatment
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Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) is slightly higher Thursday after the FDA approved the company and partner Bayer's new treatment for advanced colorectal cancer.
The agency approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.
Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application.
Shares of ONXX las traded at $83.82, up 1.6 percent.
The agency approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA's priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.
Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application.
Shares of ONXX las traded at $83.82, up 1.6 percent.
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