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

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.

Roche/Astellas Pharma Inc.’s filing for Tarceva (erlotinib) as a first-line therapy in patients with EGFR-activating mutations could establish the drug more firmly in one of the largest non-small-cell lung cancer disease subtypes.

Astellas announced Nov. 20 that it submitted a supplemental NDA for Tarceva as a first-line therapy in EGFR-mutation positive locally advanced or metastatic NSCLC, based on positive results in the...

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