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Astellas Files Personalized Tarceva In First-line Lung Cancer With FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

If successful, filing in EGFR-positive patients could give Roche/Astellas’ Tarceva a commercial boost, broadening erlotinib’s role in non-small-cell lung cancer.

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Boehringer’s Afatinib Buoyed By Priority Review In Bid For Role In EGFR-Positive Lung Cancer

FDA accepts the NDA for afatinib – among Boehringer’s first cancer drugs – for review in first-line EGFR-mutation positive non-small cell lung cancer. Filing is supported by LUX-Lung 3 study, in which the drug showed a 4.2 month progression-free survival benefit over what some describe as the most effective chemo doublet available.

Alimta Lung Cancer Label Expanded To Include Longer Use

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NSCLC Market Snapshot: Promising Biomarkers, Testing Challenges

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