The U.S. Food and Drug Administration (FDA) has approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).

Patients with such genetic mutations generally benefit from treatment with an anti-EGFR tyrosine kinase inhibitor, such as Roche’s Tarceva (erlotinib).

The diagnostic test, manufactured by the Roche Molecular Systems in Pleasanton, California, will be used as a companion diagnostic for drug Tarceva, as a form of first-line treatment for patients with NSCLC whose cancers have spread to other parts of the body.

Tarceva (erlotinib), an oral lung cancer treatment, was officially licensed as first-line monotherapy for the treatment of patients with advanced forms of non-small cell lung cancer (NSCLC) with a certain mutation, saving them from up-front chemotherapy.

According to the National Cancer Institute, lung cancer is currently one of the leading causes of cancer-related deaths, with an anticipated 228,190 new cases of the cancer this year alone (and approximately 159,480 deaths). Each year in the U.S., lung cancer kills more individuals than prostate, colon, and breast cancers combined.

NSCLC is the most common form of lung cancer, accounting for about 85 percent of cases.

Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said:

“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. Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient.”

Clinical studies demonstrated the effectiveness of the cobas EGFR Mutation Test. Patients with a specific type of EGFR mutation who received Tarceva treatment lived for 10.4 months without their disease progressing, as opposed to only 5.4 months for those who were only treated with standard two-drug chemotherapy regimen.

Those with the mutation were identified with the new diagnostic test.

On April 16, 2010, the drug Tarceva was approved by the FDA for patients suffering from locally advanced or metastatic NSCLC. It was originally approved, in 2004, for the treatment of locally advanced NSCLC following the failure of a chemotherapy regiment.

Written by Joseph Nordqvist