FDA Approves Gilotrif (afatinib) for Non-small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved a new drug to treat non-small cell lung cancer that has spread (metastasized). Gilotrif (afatinib) is for people whose tumors have certain genetic mutations in a gene called epidermal growth factor receptor (EGFR). The mutations, which change the gene so that the cells grow faster, can be detected through a test that was also approved by the FDA.

The FDA reviewed Gilotrif under its priority review program for drugs. The program is designed to get faster approval for drugs that appear to provide safe and effective treatment when no other satisfactory treatment exists, or offer a significant improvement over the existing treatments.

Most people who have lung cancer – about 85% – have non-small cell lung cancer. About 10% of that group has the genetic mutation that can be targeted by the new drug. Gilotrif is a targeted therapy drug that works by interrupting cell changes or signals that are needed for a cancer to develop and keep growing.

“Today’s approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA based its approval on a clinical trial of 345 people with metastatic non-small cell lung cancer that had EGFR mutations. They were randomly assigned to receive Gilotrif or standard chemotherapy drugs. The study showed that patients who received Gilotrif survived about as long as those who received chemotherapy, and were able to avoid the side effects of chemotherapy.

Gilotrof is taken by mouth. The most common side effects included diarrhea, skin problems, pain and sores in the mouth, and decreased appetite. Serious side effects were less common and included severe diarrhea, severe rash, lung inflammation and liver problems.

Gilotrif is marketed by Boehringer Ingelheim Pharmaceuticals, Inc.

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