Friday, OSI Pharmaceuticals, Inc. (OSIP) and Genentech, Inc., a wholly owned member of the Roche Group, announced that the U.S. Food and Drug Administration or FDA has extended the review period for the supplemental New Drug Application or SNDA for Tarceva as a first-line maintenance therapy in advanced non-small cell lung cancer or NSCLC by an additional 90 days. The extension follows OSI Pharma's submission of further data in support of the application. The original Prescription Drug User Fee Act date was January 18, 2010. The companies now anticipate FDA action on the SNDA by April 18, 2010.
OSI and Genentech will work closely with the FDA during this extended review period. According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States. It is estimated that approximately 159,000 Americans died from the disease in 2009. Most people are diagnosed with advanced stage disease and only 15% survive five years. NSCLC is the most common type of lung cancer.
Tarceva is also indicated in combination with gemcitabine chemotherapy for the first-line treatment of people with locally advanced pancreatic cancer, pancreatic cancer that cannot be surgically removed or pancreatic cancer that has spread to distant body organs.
OSIP is traded at $34.65 up $0.42 or 1.23% on a volume of 1.420 million shares on the Nasdaq.
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