Roche Receives FDA Nod for New PGx Indication for Tarceva in Metastatic NSCLC with Companion Dx | GenomeWeb

Roche has received US Food and Drug Administration approval for a new pharmacogenetic indication for the non-small cell lung cancer drug Tarceva (erlotinib) and a companion test that picks out best responders to the treatment.

The agency announced this week that it had approved Roche's Cobas EGFR Mutation test as a companion diagnostic for Tarceva when it is given as a first-line treatment for metastatic NSCLC patients whose tumors harbor certain EGFR mutations.

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