European Commission has granted marketing authorisation for afatinib monotherapy

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 program," 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, accounting for 1.6 million new cases each year.It is the most deadly; more people die of lung cancer than of colon, breast and prostate cancers combined.

In Europe alone, lung cancer is responsible for almost 270,000 deaths each year. Although incidence rates are higher in men than women it has been suggested that, by 2015, lung cancer will overtake breast cancer as the biggest cause of female cancer death in Europe.

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% in Caucasian and 40% 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.

"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," said Dr. Sanjay Popat, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, London and clinical investigator in the LUX-Lung 3 trial.

"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.

The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%).

The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%).

There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). 1% of patients in the afatinib arm discontinued due to drug-related diarrhoea.