OSI Pharmaceuticals, Inc and Genentech, Inc, a wholly owned member of the Roche Group, announced that the US 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 US FDA action on the sNDA by April 18, 2010.
OSI and Genentech will work closely with the US FDA during this extended review period.
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.
OSI Pharmaceuticals is committed towards 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.
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.