The European Commission has granted marketing authorisation to Boehringer Ingelheim's afatinib monotherapy for treatment of Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s). Afatinib will be marketed in Europe under the brand name Giotrif.

"We are delighted with the decision by the European Commission. We hope this will be the first of many registrations for drugs from our in-house oncology research programme," commented Prof Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim. "The approval of afatinib in Europe reinforces our commitment to bringing the right treatments to the right patients. This is a significant step towards meeting the substantial unmet need in lung cancer treatment."

Lung cancer is one of the most common forms of cancer, and is the most deadly; more people die of lung cancer than of colon, breast and prostate cancers combined.

Because lung cancer is more than one disease, distinct subtypes can be characterised by receptors that are frequently altered or overexpressed in cancer cells. One such molecular marker is EGFR (a member of the ErbB Family of receptors). The prevalence of tumours harbouring EGFR mutations is between 10-15 per cent in Caucasian and 40 per cent in Asian NSCLC patients.

In clinical trials, afatinib has been shown to offer patients with this type of lung cancer a significant delay in tumour progression, coupled with improvements in their lung cancer related symptoms (e.g. shortness of breath, cough and chest pain) and quality of life. Therefore, early mutation testing for EGFR status is a crucial step in the treatment-decision pathway, to give patients the opportunity to receive the appropriate personalised therapy from the start.

Dr Sanjay Popat, consultant medical oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial said, "Its unique mode of action allows afatinib to block EGFR and other members of the ErbB Family of receptors that play a key role in the growth and spread of cancers associated with a high mortality such as lung cancer." He further added, "Clinical data demonstrates afatinib’s efficacy in delaying tumour growth and improving lung cancer related symptoms, making it an important addition to our treatment options in Europe."

Following recent approvals in the US, Taiwan and Mexico, European Union approval of afatinib is based on data from the pivotal LUX-Lung 3 trial and other phase III and phase II lung cancer studies. Data from phase III LUX-Lung 3 trial have shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/ cisplatin. In addition, a subgroup analysis has shown that NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.

In the European Union, Taiwan and Mexico, afatinib is approved under the brand name GIOTRIF for the treatment of patients with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) mutations.

In the US, afatinib is approved under the brand name GILOTRIF for the first-line treatment of patients with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Afatinib is an irreversible ErbB Family Blocker, which blocks EGFR (ErbB1) as well as the other relevant members of the ErbB Family that are known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality. The covalent and, therefore, irreversible binding of afatinib is unlike other compounds which are reversible in that it provides a sustained, selective, and complete ErbB Family Blockade, and therefore may lead to a distinct therapeutic benefit.

Afatinib is currently in phase III clinical development in NSCLC and head & neck cancer.

Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs and committed to oncology by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies and is committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.