Boehringer Ingelheim announced that the New Drug Application (NDA) for afatinib has been accepted for filing and granted Priority Review by the FDA; the application is 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. Afatinib is an oral once-daily irreversible ErbB family blocker that specifically inhibits epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4.

The NDA submission for afatinib is supported by the LUX-Lung clinical trial program.  Recently, afatinib was also granted orphan drug designation. To facilitate the rapid identification of EGFR mutations, Boehringer Ingelheim is partnering with Qiagen to develop a companion diagnostic for afatinib. 

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This article originally appeared on MPR