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FDA soon to approve new anti-cancer drug Alimta.
Of all cancers, lung cancer is a number one killer. The FDA advisory committee on oncology voted unanimously to endorse the approval of Alimta to treat nonsmall-cell lung cancer after prior chemotherapy. Lilly expects the FDA to reach a final decision by year's end. The FDA advisory committee based its decision on a large Phase III clinical trial on patients with nonsmall-cell lung cancer. The trial showed that Alimta's effectiveness rivaled that of a competing drug, Taxotere, but that Alimta's side effects were less severe. Taxotere is made by Aventis (France). Lilly has three large clinical trials under way, examining different dosages of Alimta and its effectiveness when combined with other treatments. "Nonsmall-cell lung cancer is the most common variety of lung cancer," said Dr. Jeffrey Bloss, medical director for Lilly's U.S. oncology unit. "This decision will have a huge impact on society." Nonsmall-cell lung cancer affects roughly 140,000 Americans each year and more than 1 million people worldwide, according to Lilly. Alimta has generated sales of $30 million so far this year after the FDA approved it in February to treat malignant pleural mesothelioma, an asbestos-related cancer. Lilly has pursued approval for Alimta in other countries. The drug already is OK'd to treat asbestos-related cancer in Argentina, Canada and Israel. Australian authorities have approved Alimta for both asbestos-related and nonsmall-cell lung cancers. Lilly expects European Union approval to treat both types by the end of this year.
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