said Thursday that the Food and Drug Administration had approved its drug Alimta as a treatment for advanced non-small-cell lung cancer.
The FDA's decision marks the second approval for the drug, which was endorsed by the agency in February as a treatment for a type of mesothelioma, a cancer of the lung lining associated with asbestos exposure.
The FDA's action expands the cancer patient market for the drug and enables Lilly to actively promote the product for both cancers among oncologists. Companies can promote drugs only for treatments approved by the FDA, even though doctors are allowed to use a drug for any problem once it has been endorsed for any use by the FDA.
Although Alimta was approved as a mesothelioma treatment in conjunction with a standard chemotherapy drug, it was approved as a stand-alone treatment for non-small-cell lung cancer patients. Alimta is a second-line therapy for these patients, whose initial treatment with another drug didn't work or whose lung cancer has recurred.
The FDA moved quickly following an agency advisory panel's positive recommendation on According to the American Cancer Society, all forms of lung cancer afflict 174,000 people each year. Non-small-cell lung cancer accounts for about 80% of those cases.
The FDA announcement apparently was anticipated by investors. In early afternoon trading, Lilly's stock was down 53 cents, less than 1%, to $64.03.