-- Scott Roberts
FRIDAY, July 12 (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
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 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.
To learn more about this approval, visit the
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