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

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.

Roche's real-time PCR-based Cobas EGFR test is for the qualitative detection and quantification of exon 19 deletion or exon 21 (L858R) substitution mutations in the EGFR gene in DNA derived from formalin-fixed, paraffin-embedded tumor tissue from NSCLC patients.

"Increasingly, doctors and patients rely on diagnostics to help guide personalized treatment decisions. The approval of the Cobas EGFR Mutation Test highlights the importance of sensitive, accurate tests that can be conducted in time to inform crucial treatment decisions," Paul Brown, head of Roche Molecular Diagnostics, said in a statement.

The test was validated in the European Randomized Trial of Tarceva versus Chemotherapy, or EURTAC, study, during which the drug was evaluated as a first-line treatment and compared with platinum-based chemotherapy in NSCLC patients with the EGFR mutation.

Tarceva is also FDA-approved for patients with advanced stage NSCLC that has not spread or grown after treatment with certain types of chemotherapy. Additionally, it is approved for advanced stage NSCLC patients whose cancer has grown or spread after patients received at least one chemotherapy regimen. It is not for use simultaneously with certain types of chemotherapy for advanced NSCLC.