FDA delays approval of OSI/Genentech/Roche's Tarceva for advanced non-small cell lung cancer

USA-based firms OSI Pharmaceuticals and Genentech, a wholly-owned subsidiary of Swiss drug major Roche' announced last Friday that the US Food and Drug Administration 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), thus delaying action on the drug 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 by April 18, 2010.

OSI and Genentech will work closely with the FDA during this extended review period. OSI Pharmaceuticals is seeking FDA approval for Tarceva, which is co-marketed with Roche for patients whose disease has not progressed after completing chemotherapy.