15 April 2016 - Boehringer Ingelheim today announced that the U.S. FDA has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib dimaleate) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

The U.S. approval follows the recent marketing authorization of Gilotrif in this patient population by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

For more details, go to: http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2016/4-15-2016-fda-approves-gilotrif-afatinib-oral-treatment-option-patients-squamous-cell-carcinoma-lung.html