In January, the U.S. Food and Drug Administration granted priority status to the anti-cancer compound Gilotrif (afatinib). Now, the FDA has granted approval to the drug for patients with late stage non-small cell lung cancer whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. The EGFR mutation has been found in certain populations of lung cancer and mesothelioma patients.
EGFR is a primary biomarker focused on by researchers hoping to find new, effective treatments for lung cancer and mesothelioma patients. The EGFR gene, a protein found on the surface of some cells to which epidermal growth factor binds and causes the cells to divide and spread, is found at abnormally high levels on the surface of many types of cancer cells including over 50% of pleural mesothelioma patients.
“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 July 12 press release.
According to the FDA, Gilotrif’s safety and effectiveness were established in a clinical study of 345 participants with metastatic NSCLC whose tumors harbored EGFR mutations. The participants who received Gilotrif had a delay in tumor growth that was 4.2 months later than those receiving chemotherapy. There was no statistically significant difference in overall survival.
Gilotrif was approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations, according to the press release.
This approval offers mesothelioma patients an option for a treatment that uses the unique characteristics of their disease when the EGFR mutation is present. Patients who receive personalized treatment and targeted therapies have an increased chance of survival and a better quality of life while battling the disease.
Gilotrif is developed by Boehringer Ingelheim, one of the world’s 20 leading pharmaceutical companies, headquartered in Ingelheim, Germany.
More articles by Nancy Meredith
Nancy Meredith is a blog and web content writer with more than 20 years of professional experience in the Information Technology industry. She has been writing about Mesothelioma for 4 years. Follow Nancy on Google+
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