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FDA approves first companion diagnostic test for cancer drug


08:53, May 15, 2013

WASHINGTON, May 14 (Xinhua) -- The U.S. Food and Drug Administration has approved for the first time a companion diagnostic test for cancer drug Tarceva from Roche to detect certain gene mutations in the most common form of lung cancer known as non-small cell lung cancer (NSCLC).

Lung cancer is the leading cause of cancer-related death among men and women, and about 85 percent of lung cancers are NSCLC. The FDA said about 10 percent of NSCLC patients have certain mutations in a gene called epidermal growth factor receptor (EGFR).

"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 Office of In Vitro Diagnostics and Radiological Health in a statement on Tuesday.

"Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient," Gutierrez said.

The approval is Tarceva's fourth indication and the third use for lung cancer. The FDA approved Tarceva in 2010 for patients with locally advanced or metastatic NSCLC whose disease hasn't progressed after four cycles of chemotherapy. Tarceva was originally approved in 2004 for patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Tarceva is co-marketed by California-based Genentech, a member of the Roche Group and OSI Pharmaceuticals.

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