Boehringer Ingelheim's afatinib NDA gets priority review in USA

The US subsidiary of German independent drug major Boehringer Ingelheim revealed yesterday that the New Drug Application for its investigational oncology compound afatinib, proposed trade name Tomtovok, has been accepted for filing and granted Priority Review by the US Food and Drug Administration.

The application for afatinib, the German firm’s first cancer drug candidate, 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. Under the Prescription Drug User Fee Act (PDUFA), the FDA goal for reviewing a drug with Priority Review status is six months from the NDA filing acceptance date, thus the action date for afatinib will be in the third quarter of 2013.

Recently, afatinib was also granted orphan drug designation - a status given to a product intended for the treatment of a rare disease or condition. In the USA, orphan drug status provides for seven years of market exclusivity for the orphan drug indication following FDA approval. Currently there are no therapies specifically approved by the agency for patients with locally advanced or metastatic NSCLC with an EGFR mutation.