OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) 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
SOURCE OSI Pharmaceuticals