15 January 2013 - 15 January 2013 - US Boehringer Ingelheim Pharmaceuticals Inc, part of German Boehringer Ingelheim Corp, said today that the US Food and Drug Administration (FDA) had given a priority review to its New Drug Application (NDA) for the investigational oncology compound afatinib.

The compound is an oral, once-daily irreversible ErbB Family Blocker, inhibiting the epidermal growth factor receptor (EGFR or ErbB1), human epidermal receptor 2 (HER2 or ErbB2) and ErbB4.

The regulator’s decision on the approval of afatinib as a treatment for 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 is expected between July and September.

The afatinib NDA is based on data from a Phase III clinical study, dubbed LUX-Lung, carried out in EGFR mutation-positive, locally advanced or metastatic NSCLC patients.

The compound has recently obtained an orphan drug designation by the FDA, providing Boehringer Ingelheim with a seven-year term of market exclusivity following the agency clearance.

In September 2012, Boehringer Ingelheim filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for the compound to be used as a treatment of patients with EGFR (ErbB1) mutation-positive NSCLC.

Currently, the company and the Dutch genetic-testing specialist Qiagen (ETR:QIA) are collaborating on the development of a companion diagnostic for afatinib, the therascreen EGFR RGQ PCR kit, which identifies patients with EGFR mutation-positive tumours.