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Tarceva NDA gets rolling

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Roche/Genentech/OSI expect to complete the rolling NDA for Tarceva (erlotinib) in mid-2004, for treatment of incurable stage IIIB/IV non-small cell lung cancer in patients who have failed standard therapy for advanced or metastatic disease. OSI announced submission of preclinical and chemistry, manufacturing & controls sections of the NDA Jan. 21. Data from a 730-patient, Phase III monotherapy study in refractory NSCLC is expected in the second quarter. Last October, the firms reported that the Phase III program examining Tarceva in combination with standard chemotherapy failed to show a survival benefit. In contrast to the combo trials, the study design for the monotherapy trial "was based on very solid Phase II data," OSI CEO Colin Goddard, PhD, said. Approval is expected at the end of 2004…

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