The U.S. Food and Drug Administration approved a new drug Gilotrif that will be used to treat patients with late stage, non-small cell lung cancer (NSCLC).
Lung cancer is the leading cause of cancer-related deaths among men and women. The National Cancer Institute predicts that approximately 228,190 Americans will be diagnosed with lung cancer, and 159,480 will die from the disease this year. More than 85 percent of all lung cancers are of the non-small cell lung cancer (NSCLC) type, making it the most common type of lung cancer.
On Friday, July 12, the U.S. Food and Drug Administration approved a new drug Gilotrif that will be used in the treatment of late stage of this type of cancer. The drug will be used to treat tumors that may carry key deletions on the epidermal growth factor receptor (EGFR) gene and can help as a target for lung cancer therapeutics. Mutations of the EGFR gene have been thought to occur in about 10 percent of non-small cell lung cancers and most of these mutations are targeted by Gilotrif.
"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, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research in a press release. "Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations."
The effectiveness and safety of the drug were tested in a clinical study where 345 individuals with metastatic NSCLC whose tumors harbored EGFR mutations took part. Participants were randomly assigned to receive Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin. Researchers observed that participants that received the drug had a delay in tumor growth of about 4.2 months compared to those who received chemotherapy. However, there was not much of a difference in the survival times of all patients.
The side effects of the drug include diarrhea, skin breakouts that resemble acne, dry skin, itching (pruritus), inflammation of the mouth, skin infection around the nails (paronychia), decreased appetite, decreased weight, inflammation of the bladder (cystitis), nose bleed, runny nose, fever, eye inflammation and low potassium levels in the blood (hypokalemia). Serious side effects include diarrhea that can result in kidney failure and severe dehydration, severe rash, lung inflammation and liver toxicity.
Gilotrif is not the first lung-cancer treating drug to be approved by the FDA this year. Earlier in May, the administration approved Tarceva for first-line treatment of patients with NSCLC.
