The U.S. Food and Drug Administration has given premarket approval to the cobas® EGFR Mutation Test from Roche Molecular Systems, creating a possible future option for metastatic lung cancer patients.
The test is designed to detect the presence of mutations in the epidermal growth facto receptor in metastatic non-small cell lung cancer. Mutations in the EGFR gene lead to abnormal functioning of the EGFR protein and to cancer cell growth for this specific type of lung cancer.
The test will be used to help physicians select patients with metastatic non-small cell lung cancer for treatment with a drug called TARCEVA (erlotinib). The medication is an EGFR inhibitor.
The FDA approved the application May 14.