Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for afatinib 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. The FDA target action date for afatinib will be in the third quarter of 2013.
Afatinib has demonstrated a significant delay in tumour growth versus the best-in-class chemotherapy, which resulted in 11.1 months progression free survival (PFS) vs. 6.9 months in the comparator arm. Afatinib is currently under review by the European Medicines Agency (EMA) following submission for Marketing Authorisation in Europe in August 2012.
"The acceptance of the NDA filing reinforces our ongoing commitment to oncology as we take the necessary steps to seek approval for our first cancer treatment, in an area of high unmet medical need," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "We are excited that the positive clinical data for afatinib is now currently under review by both the FDA and EMA and look forward to working diligently with both agencies in the hope that people with lung cancer can soon benefit from this new treatment."