Amgen gets expanded approval for colon cancer drug
THOUSAND OAKS, Calif. (AP) — Amgen Inc. said Friday its cancer drug Vectibix received expanded approval in the U.S. to treat patients with a genetic variation of advanced colon cancer.
The company said the Food and Drug Administration cleared its biotech drug as a first-choice option against colorectal tumors with an abnormal gene known as KRAS, in combination with chemotherapy.
Patients taking Vectibix combined with chemotherapy lived 4.4 months longer than patients on chemotherapy alone, Amgen said in a statement.
FDA approved the drug alongside a genetic test to help doctors quickly determine whether patients are likely to respond to the drug. The test, developed by Qiagen NV, detects the KRAS gene mutation. About 40 percent of patients with colorectal cancer have such variations, which affect their response to drugs like Vectibix.
Vectibix was first approved in 2006 as a treatment for patients with colon cancer that has spread despite treatment with other drugs. The most common side effects with Vectibix include skin rash, fatigue, diarrhea, nausea and constipation.
Amgen reported U.S. sales of $126 million for the drug in 2013.
Colon cancer is the third most common cancer in men and women in the U.S., causing more than 50,000 deaths, according to the Centers for Disease Control and Prevention.