US FDA approves companion diagnostic for Tarceva, and new indication for the Roche drug

The US Food and Drug Administration late yesterday (May 14) approved Swiss drug major Roche (ROG: SIX) subsidiary Genentech’s cobas EGFR Mutation Test, a companion diagnostic for their 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% of non-small cell lung cancers (NSCLC), the regulatory agency noted.

The test is being approved with an expanded use for Tarceva as a first-line treatment for patients with NSCLC that has spread to other parts of the body (metastasized) and who have certain mutations in the EGFR gene.

“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 Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient,” Dr Gutierrez noted.