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FDA decision for Tarceva in 1st-line NSCLC expected 2Q

This article was originally published in Scrip

Executive Summary

The US FDA accepted for review Astellas' supplemental new drug application (sNDA) for Tarceva (erlotinib) as a first-line therapy for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations, which will be verified using a companion diagnostic test from Roche Molecular Diagnostics.

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