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View Full Version : Boehringer Ingelheim files MAA with EMA for afatinib approval


News
09-20-2012, 03:01 AM
Today, Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for approval of afatinib, the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support for this submission.

More... (http://www.news-medical.net/news/20120920/Boehringer-Ingelheim-files-MAA-with-EMA-for-afatinib-approval.aspx)