The U.S. Food and Drug Administration has approved use of the drug Gilotrif for patients with a form of late stage non-small cell lung cancer.
Lung cancer is the leading cause of cancer-related death among men and women. According to the National Cancer Institute, an estimated 228,190 Americans will be diagnosed with lung cancer, and 159,480 will die from the disease this year.
The new drug is approved for treatment of late stage non-small cell lung cancer with a specific gene mutation. Late stage non-small cell cancer accounts for about 85 percent of all lung cancer, and the mutations to be treated by Gilotrif account for about 10 percent of late stage non-small cell cancer.
Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells.
“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 Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
Gilotrif’s safety and effectiveness were established in a clinical study of 345 participants. Those receiving Gilotrif had a delay in tumor growth that was 4.2 months later than those receiving chemotherapy. There was no statistically significant difference in overall survival.
The FDA reviewed Gilotrif under its priority review program, which provides an expedited review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
Gilotrif is marketed by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals, Inc.