FDA Approves Lung Cancer Drug, Gilotrif

The U.S. Food and Drug Administration has just approved a new drug for non-small cell lung cancer (NSCLC).

Gilotrif (afatinib) is approved to treat patients with a specific subtype of the lung cancer cells, which accounts for about 85 percent of lung cancers.

According to the FDA, Gilotrif is approved to treat tumors that may carry key deletions on the epidermal growth factor receptor (EGFR) gene and can help as a target for lung cancer therapeutics. Mutations of the EGFR gene have been thought to occur in about 10 percent of non-small cell lung cancers and most of these mutations are targeted by Gilotrif.

Experts have applauded the drugs approval, stating that it may provide an alternative to chemotherapy in some instances.

"This drug represents a new important alternative to standard chemotherapy in the 10 to 15 percent of lung cancer patients who have EGFR mutations," said Dr. Jorge Gomez, medical director of the thoracic oncology program at Mount Sinai Medical Center in New York City, via U.S. News and World Report. The new medication "is the first drug to be developed and approved for patients selected for EGFR mutations," he added, according to the news organization.

Gilotrif is marketed by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals, Inc. The therascreen EGFR RGQ PCR Kit is manufactured by QIAGEN Manchester Ltd., based in the United Kingdom. The cobas EGFR Mutation Test is manufactured by the Roche Molecular Systems in Pleasanton, Calif., and Tarceva is co-marketed by California-based Genentech, a member of the Roche Group, and OSI Pharmaceuticals of Farmingdale, N.Y.