FDA approves genetic test for lung cancer drug

May 14, 2013

The Food and Drug Administration says it approved a genetic test from Roche to help doctors identify patients who can benefit from a lung cancer drug made by Genentech.

The diagnostic test is the first approved to detect 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 expanded the drug's approval for that use in an announcement Tuesday. The drug was previously approved only as a second-line option after patients had failed to respond to chemotherapy.

Lung cancer is the deadliest form of cancer among both men and women in the U.S.

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