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Genentech/OSI Tarceva NDA

Executive Summary

OSI/Genentech's NDA for use of Tarceva as monotherapy in the treatment of non-small cell lung cancer accepted into FDA's Pilot 1 Program for rolling NDAs, OSI says June 29. The rolling NDA for erlotinib started in January (1"The Pink Sheet" June 14, 2004, p. 6). Under the program, FDA is committed to initiate review of the submitted CMC and non-clinical sections on a six-month review timeline as of the notification of Pilot I status. OSI expects to complete the NDA submission by the end of the summer, making approval possible in early 2005...
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