Lung Cancer

"Rolling" NDA submission initiated for Tarceva

Published in Medical Letter on the CDC and FDA, February 22nd, 2004

OSI Pharmaceuticals, Inc., (OSIP) announced that it has initiated the "rolling" submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for the use of Tarceva (erlotinib HCl) in the treatment of patients with incurable stage IIIB/IV non-small cell lung cancer (NSCLC) who have failed standard therapy for advanced or metastatic disease.

Data from this clinical trial are now expected in the second quarter of this year and additional components of the NDA filing will be provided to the FDA after these data are available. Tarceva is designed to block tumor cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor...

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Source: Medical Letter on the CDC and FDA (2004-02-22)

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