Gilotrif FDA-approved to treat late-stage lung cancer
US Food and Drug Administration
(HealthDay News) -- The drug Gilotrif (afatinib) has been approved by the U.S. Food and Drug Administration to treat spreading cases of non-small-cell lung cancer (NSCLC) caused by certain gene mutations, the agency said Friday.
The treatment, given priority FDA review, was sanctioned for tumors that express certain epidermal growth factor receptor (EGFR) mutations, as detected by a newly approved diagnostic, the agency said in a news release.
Lung cancer is the number one cause of cancer-related death in both men and women, the FDA said. The disease is likely to be diagnosed in some 228,190 people this year, and is predicted to kill about 159,480, the U.S. National Cancer Institute said. EGFR mutations are found in about 10 percent of NSCLC cases.
Gilotrif is designed to block proteins that spur development of cancer cells, the FDA said. The drug was approved along with a companion diagnostic called the therascreen EGFR RGQ PCR Kit, which helps doctors determine if a person's lung cancer cells express the EGFR mutations.
Gilotrif's safety and effectiveness were evaluated in clinical studies involving 345 people with spreading NSCLC whose tumors had EGFR mutations. The most common side effects were skin breakouts, dry and itchy skin, mouth inflammation, infection near the nails, and decreased weight and appetite.
Among those who received Gilotrif, progression-free survival was 4.2 months longer than for those who received chemotherapy, the FDA said. There was no statistically significant difference in overall survival, the agency added.
Gilotrif is produced by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals. The companion diagnostic is manufactured by the British firm Qiagen Manchester Ltd.