Boehringer files Tomtovok at EMA for NSCLC - 21-Sep-2012

Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency for approval of Tomtovok (afatinib) the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive Non-Small Cell Lung Cancer. Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support for this submission. see Abstract no: LBA7500, LUX-Lung 3: "A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations." Oral Presentation at 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012.