Priority Review Granted to Afatinib for Advanced NSCLC

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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