U.S Food and Drug Administration (FDA) has approved a new weapon(Gilotrif) to treat patients with metastatic non-small cell lung cancer (NSCLC). Such type of patients also posses mutation in the gene of epidermal growth factor (EGFR) shown by their tumors as determined by FDA approved test.
Lung cancer targets men and women equally. It has been predicted by National Cancer Institute that approximately 228,190 people in United State will be diagnosed and 159,480 people will die in this year due to lung cancer.
Gilotrif is a tyrosine kinase blocker and prevent the development of cancerous cells by inhibiting the protein that play important role in the growth of tumor 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 Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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 first line treatment of NSCLC is Tarceva (erlotinib) and was approved by FDA in May.
“The approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The safety and effectiveness of Gilotif was evaluated by conducting clinical trials on 345 patients suffering from NSCLC with EGFE mutations. All enrolled patients received either Gilotrif or six cycles of chemotherapy drugs named as pemetrexed and cisplatin.
Common side effects:
The common side effects associated with Gilotrif include;
- Dry skin
- Mouth inflammation
- Skin infections
- Loss of appetie and weight
- Runny nose
- Nose bleeding
- Eye inflammation
- Hypokalemia (less potassium levels)
Some serious side effects are;
- Severe diarrhea
- Severe dehydration
- Kidney failure
- Lung inflammation
- Skin rashes
Gilotrif is marketed by Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals, Inc.
Source: FDA News