Amgen Colorectal Cancer Drug Gains Expanded U.S. Approval

Amgen Inc. (AMGN) won expanded U.S. approval for its drug Vectibix as an initial treatment in patients with a type of advanced colorectal cancer who first undergo genetic screening.

The drug was cleared by the Food and Drug Administration as an initial treatment in conjunction with chemotherapy for patients whose tumors have a gene mutation that renders their cancer susceptible to the medicine, the Thousand Oaks, California-based company said today in a statement. The agency also cleared Qiagen NV’s (QGEN) test that can show whether Amgen’s drug will be effective in patients, the companies said.

Qiagen’s product, therascreen, has now been approved for use with two drugs to fight colorectal cancer after it has spread. The test was approved in July 2012 to be used in conjunction with Bristol-Myers Squibb Co. and Eli Lilly & Co.’s Erbitux, which isn’t effective in people whose tumors have the KRAS mutation. The mutation occurs in about 40 percent of colorectal cancer patients, according to Qiagen.

“Because every patient with cancer is unique, we have made it our mission to focus on identifying treatment options for patients based on their cancer’s genetic makeup,” Sean Harper, executive vice president of research and development at Amgen, said in the statement.

The approval is “an example of the advancements that can be made through a greater understanding of distinct genetic markers associated with difficult-to-treat diseases,” Harper said.

Cancer of the colon or rectum is the third-most common type in men and women in the U.S. and the second-leading cause of cancer deaths, according to the American Cancer Society. About 137,000 new cases are expected in the U.S. this year, and more than 50,000 deaths.

Vectibix had about $389 million in sales in 2013, according to data compiled by Bloomberg. It was previously approved for use in colorectal cancer patients whose disease progressed after treatment with chemotherapy.

To contact the reporter on this story: Alex Wayne in Washington at awayne3@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Andrew Pollack, Bruce Rule

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