The U.S. Food and Drug Administration (FDA) this week approved Roche Molecular Systems’ cobas® EGFR Mutation Test as a companion diagnostic for erlotinib (Tarceva), the cancer drug it also approved for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors show EFGR exon 19 deletions or exon 21 substitution mutations.

The agency said it based these approvals on the results of a randomized, multicenter, open-label trial comparing erlotinib to platinum-based doublet chemotherapy in patients with metastatic NSCLC whose tumors showed EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

FDA noted that Roche’s cobas is the first companion diagnostic it has approved to detect gene mutation associated with a type of lung cancer, adding that EGFR mutations are exhibitied in about 10% of NSCLC cases.

“The approval of the cobas EGFR Mutation Test will allow physicians to identify non-small cell lung cancer patients who are candidates for receiving Tarceva as first-line therapy,” said FDA’s Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health, in a statement. “Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient.”

Tarceva, which is co-marketed by Genentech, received initial FDA approval in November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen, the agency said.

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