FDA Approves Roche Test as CDx for Tarceva for Treating Certain NSCLC Patients | GenomeWeb

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's companion diagnostic test for Tarceva (erlotinib), Roche announced Tuesday night.

Roche also said that FDA approved Tarceva as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors have certain epidermal growth factor receptor mutations as detected by the Cobas EGFR Mutation Test.

Tarceva is jointly marketed in the US by Roche's Genentech business and Astellas Pharma US, a subsidiary of Tokyo-based Astellas Pharma.

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