FDA approves Gilotrif for late-stage lung cancer
FDA Approves Gilotrif for Late-Stage Lung Cancer
HealthDay News -- The FDA has approved afatinib (Gilotrif) to treat spreading cases of non-small-cell lung cancer (NSCLC) caused by certain gene mutations.
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 press release.
Lung cancer is the number one cause of cancer-related death in both men and women. Approximately 228,190 people will be diagnosed with the disease this year, of whom about 159,480 will die, the U.S. National Cancer Institute estimates. EGFR mutations are found in about 10% of NSCLC cases.
Afatinib is designed to block proteins that spur development of cancer cells. 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.
Afatinib's safety and effectiveness were evaluated in clinical studies involving 345 people with spreading NSCLC whose tumors had EGFR mutations. Among those who received afatinib, 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.
The most common side effects were skin breakouts, dry and itchy skin, mouth inflammation, infection near the nails and decreased weight and appetite.
Afatinib is produced by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals. The companion diagnostic is manufactured by the British firm Qiagen Manchester Ltd.