FDA Approves Boehringer Drug for Lung Cancer

July 12, 2013 (AP) - The Food and Drug Administration said Friday it approved a new drug from Boehringer Ingelheim for patients with a genetic variant of advanced lung cancer.

The agency said it approved the company's Gilotrif for lung cancer patients that test positive for certain gene mutations in their tumors. The agency approved the drug alongside a diagnostic test from Qiagen NV designed to detect the mutation. The test detects epidermal growth factor receptor abnormalities found in roughly 10 percent of patients with the most prevalent form of lung cancer, known as non-small cell lung cancer.

Lung cancer is the deadliest form of cancer among men and women in the U.S. and is expected to kill nearly 160,000 people this year, according to the National Cancer Institute.

The FDA specifically approved the drug for untreated cancer that has spread from the lungs.

"The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them," said Alberto Gutierrez, FDA's director of in vitro diagnostics.

Shares of Netherlands-based Qiagen NV rose 73 cents, or 3.8 percent, to $20.68 in trading. Boehringer Ingelheim is based in Germany.

NewsEdge

Posted: July 2013


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