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The diagnostic test is the first approved to detect genetic mutations found in roughly 10 percent of patients with the most prevalent form of lung cancer, known as non-small cell lung cancer. Patients who test positive for the mutation are more likely to respond to Genentech's drug Tarceva as a first-choice treatment, and the FDA said it expanded the drug's approval for that use in its announcement. The drug was originally approved in 2004 as a second-line option after patients failed to respond to chemotherapy. Lung cancer is the deadliest form of cancer among men and women in the U.S. and is expected to kill nearly 160,000 people this year, according to the National Cancer Institute. Company studies found that patients with the genetic mutation detected by Roche's test lived more than 10 months without their disease progressing, when treated with Tarceva. That compared to more than five months for patients taking a standard chemotherapy drug combination. "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 FDA's office for diagnostics, in a statement. "Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient. The test approved by the FDA is one of a number of "cobas" diagnostics developed by Roche. |
