FDA Grants Priority Review to Boehringer Ingelheim Corporation’s Afatinib* NDA for EGFR Mutation-Positive Advanced NSCLC
1/16/2013 9:36:46 AM
INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib* has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for afatinib* is currently under review for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation as detected by an FDA-approved test. The FDA target action date for afatinib* will be in the third quarter of 2013.