An announcement by Boehringer Ingelheim indicated that they had received an expanded FDA approval of a new indication for afatinib (Gilotrif). The approval includes using the drug as a first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) in the rare subset of patients whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.
Afatinib was initially approved in the United States in 2013 for patients with squamous cell carcinoma of the lung whose disease progressed after treatment with platinum-based chemotherapy. Today’s approval is based on results from 3 different studies from the LUX-Lung clinical trial program (Phase II LUX-Lung 2 study and Phase III studies LUX-Lung 3 and LUX-Lung 6) that examined the drug in 32 NSCLC patients whose tumors had EGFR mutations, including L861Q, G719X or S768I.
The FDA’s approval was based on the results of three clinical trials that demonstrated afatinib's activity in these mutations based on objective response rate, duration of response, disease control, progression-free survival and overall survival.
“With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations,” said Sabine Luik, M.D., senior vice president of Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. in a press release. “This approval is a result of our company’s commitment to delivering meaningful treatment advances in areas with high unmet medical need and reflects the tireless efforts of physicians, researchers and patients who participated in our studies.”
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.