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OSI Pharmaceuticals and Genentech announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days
MELVILLE, NY, & SOUTH SAN FRANCISCO, CA, USA | Janaury 15, 2010 | OSI Pharmaceuticals, Inc. (NASDAQ: OSIP - News) and Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. The extension follows OSI’s submission of further data in support of the application. The original Prescription Drug User Fee Act (PDUFA) 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.
About SATURN
SATURN was an international, placebo-controlled, randomized, double-blinded, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress. The co-primary endpoints were progression-free survival (PFS) in all patients and PFS in patients whose tumors over-expressed the epidermal growth factor receptor (EGFR) as assessed by Immunohistochemistry (IHC). PFS was defined as the length of time from randomization to disease progression or death from any cause. Secondary endpoints included overall survival, safety and an evaluation of exploratory biomarkers.
About Lung Cancer
According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States. It is estimated approximately 159,000 Americans died from the disease in 2009. Most people are diagnosed with advanced stage disease and only 15 percent survive five years. NSCLC is the most common type of lung cancer.
About Tarceva
Tarceva is a once-a-day pill that targets the EGFR pathway. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cancer cell, one of the critical growth factors in NSCLC and pancreatic cancer. Tarceva is indicated as a monotherapy for people with locally advanced or metastatic NSCLC whose disease has progressed after one or more courses of chemotherapy. Tarceva is not intended to be used at the same time as chemotherapy for NSCLC.
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.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity. For additional information about OSI, please visit http://www.osip.com.
About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech |
