The US Food and Drug Administration (FDA) has accepted Boehringer Ingelheim's New Drug Application (NDA),  afatinib, an investigational oncology compound for filing and granted Priority Review.

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.

Prof. Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim said, "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." He further added, "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."

The NDA submission is based on the comprehensive LUX-Lung clinical trial programme. Data from the pivotal LUX-Lung 3 trial, comparing afatinib to pemetrexed and cisplatin, considered best-in-class chemotherapy for non squamous NSCLC2, demonstrated superiority in progression-free survival (PFS) in patients with stage IIIb or IV adenocarcinoma of the lung harbouring an EGFR mutation. Patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing (PFS of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed / cisplatin). Importantly, patients taking afatinib with the most common EGFR mutations (del19 and L858R, accounting for 90 per cent of all EGFR mutations) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.

In addition, patients treated with afatinib experienced better and longer control and improvement of the most common lung cancer-related symptoms and better quality of life (QoL) compared to chemotherapy (pemetrexed and cisplatin). Importantly, afatinib treatment led to improved physical, role and cognitive functioning, and overall better QoL.

The most common adverse events associated with afatinib treatment were diarrhoea and rash/acne. These adverse events were as expected with EGFR inhibition, consistent with previous studies, and were manageable and reversible. These rarely led to discontinuation of afatinib treatment.

Boehringer Ingelheim strives to make afatinib available to patients around the world. Further submissions worldwide are currently under preparation.

Afatinib is an irreversible ErbB Family Blocker which targets inhibition of signal transduction of all kinase receptors from the ErbB Family4, which is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). Afatinib is currently also in phase III clinical development in breast cancer and head & neck cancer.

In Europe, Boehringer Ingelheim announced submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation-positive NSCLC in August 2012.

Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to advance the disease area.