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.
For more information call (800) 542-6257 or visit www.boehringer-ingelheim.com