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Non-Small Cell Lung Cancer

Genentech and partner announce NDA completion for Tarceva

Published in Medical Letter on the CDC and FDA, September 5th, 2004

OSI Pharmaceuticals, Inc., (NASDAQ: OSIP) and Genentech, Inc., (NYSE: DNA) announced that OSI completed the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for Tarceva (erlotinib HCl).

The NDA was submitted for Tarceva as a monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) for whom chemotherapy has failed.

"This submission completes the Tarceva NDA filing and is a major milestone in our commitment to providing relapsed lung cancer patients with this potential new treatment option as quickly as possible," stated Colin Goddard, PhD, chief executive officer of OSI...

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