EU approves Onyx and Bayer's cancer pill Stivarga

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Associated Press

Posted on August 31, 2013 at 2:01 PM

NEW YORK (AP) — Onyx Pharmaceuticals and Bayer said Friday that European Union regulators approved their pill Stivarga as a treatment for colorectal cancer.

The companies said Stivarga was approved for the treatment of metastasized colorectal cancer in adults.

In the U.S. Stivarga is approved as a treatment for two types of cancer. One is metastasized colorectal cancer in patients who have already received certain types of chemotherapy. The other is gastrointestinal stromal tumors, a type of tumor occurs in the intestinal tract, that are either inoperable or have metastasized after previous treatment.

The Food and Drug Administration first approved Stivarga in late September. In the first six months of 2013 sales totaled about $113 million.

Onyx Pharmaceuticals Inc. and Bayer AG also market Nexavar, a cancer pill used to treat tumors of the liver or kidneys. Sales of Nexavar totaled $485 million in the first half of 2013. On Tuesday the companies said the FDA will conduct a faster review of Nexavar as a treatment for thyroid cancer. The agency is expected to make a ruling by Dec. 25.

On Sunday Amgen Inc. agreed to buy Onyx for about $10.4 billion, or $125 per share.

Onyx's only other approved drug is Kyprolis, a treatment for multiple myeloma, a cancer of the blood.

Shares of Onyx slipped 3 cents to $123.57 in morning trading Friday.

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