Gilotrif® is New Treatment Option for Second Largest Lung Cancer Sub-type
Germany based Boehringer Ingelheim’s Gilotrif® (afatinib) received US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) as a novel oral treatment option for advanced squamous cell carcinoma of lung in patients whose symptoms showed progression after platinum-based chemotherapy.
After the FDA approval, Gilotrif® recently received the marketing authorization in this group of patient by European Commission. Gilotrif® is already approved in more than 60 countries as an oral, once-daily first-line treatment option for particular types of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) and now with the FDA approval it is set to become the second line treatment option for the second largest subcategory of NSCLC which comprises 20-30% of all cases.
NSCLC is a type of epithelial lung cancer in which the malignant cell is formed in the tissues of the lungs. Among the several types of NSCLC the common ones are- squamous cell carcinoma, large cell carcinoma and adenocarcinoma. Smoking increases the risk of NSCLC in a person. The current treatment options available worldwide is not enough to cure the disease and patients are recommended to participate in the ongoing global clinical trials for the improvement in the symptoms.
LUX-Lung 8 Phase III clinical trial was carried out in the squamous cell carcinoma patients with progressed symptoms after platinum-based chemotherapy and the results were compared with the FDA approved first line treatment option for NSCLC– Tarceva® (erlotinib). Gilotrif® successfully met the primary and secondary end point of delaying the progression of lung cancer and improvement in the overall survival, respectively.
“We are pleased to bring a proven therapy to patients suffering from advanced squamous cell carcinoma of the lung who have progressed despite chemotherapy,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “This approval is further evidence of Boehringer Ingelheim’s strong commitment to bringing new treatment options to the lung cancer community.”
Featured image credit: Small-cell Lung Cancer Of A Human © bond80 (Stock Photo ID: 43000186)