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GIOTRIF® (afatinib)* approved in Europe for patients with EGFR mutation positive lung cancer
Patients with EGFR mutation positive lung cancer in the European Union can now benefit from a new targeted treatment option, GIOTRIF®, the first irreversible ErbB Family Blocker
Afatinib has been shown to delay tumour progression and improve disease related symptoms versus standard chemotherapy1
Afatinib approval marks the first registration of a targeted treatment from Boehringer Ingelheim’s oncology portfolio in the EU
Ingelheim, Germany, (September 25, 2013) – Boehringer Ingelheim announced today that the European Commission has granted marketing authorisation for afatinib monotherapy, for the 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 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.2 It is the most deadly; more people die of lung cancer than of colon, breast and prostate cancers combined.3 In Europe alone, lung cancer is responsible for almost 270,000 deaths each year.4 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.4
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.5
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.1,6 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 U.S., 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.1
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.1
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 U.S., afatinib is approved under the brand name GILOTRIFTM 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.7
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.8,9
Afatinib is currently in Phase III clinical development in NSCLC and head & neck cancer.
About Boehringer Ingelheim in Oncology
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. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centres, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumours and haematological cancers.
The current focus of research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. In the EU, Taiwan and Mexico, afatinib is approved under the brand name GIOTRIF®, and in the U.S. under the brand name GILOTRIFTM for use in patients with distinct types of NSCLC. Afatinib is under regulatory review by health authorities in Asia and other countries. Nintedanib†, an angiogenesis inhibitor is currently in Phase III clinical development in NSCLC and ovarian cancer. In the area of cell-cycle kinase inhibition, volasertib† is in phase III development for acute myeloid leukaemia.
Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to advance the disease area.
*In the EU, Taiwan and Mexico, afatinib is approved under the brand name GIOTRIF®, and in the U.S. under the brand name GILOTRIFTM for use in patients with distinct types of NSCLC. Afatinib is under regulatory review by health authorities in Asia and other countries.
†Nintedanib and volasertib are investigational compounds and are not yet approved. Their safety and efficacy have not yet been fully established.
Sequist L, Yang J, Yamamoto N, et al. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With Epidermal Growth Factor Receptor Mutations. J Clin Oncol 2013;DOI: 10.1200/JCO.2012.44.2806.
Ferlay J et al. Estimates of worldwide burden of cancer in 2008:GLOBOCAN 2008. International Journal of Cancer. 2010; 127 2893-2917.
American Cancer Society. What are the key statistics about lung cancer. Available at http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics. Last accessed, September 2013.
Malvezzi M et al. European cancer mortality predictions for the year 2013. Annals of Oncology, 2013.
Jang, T.W. et al. 2009. EGFR and KRAS Mutations in Patients With Adenocarcinoma of the Lung. The Korean Journal of Internal Medicine, March; 24(1), pp.48–54.
Yang J, Hirsh V, Schuler M, et al. Symptom Control and Quality of Life in LUX-Lung 3: A Phase III Study of Afatinib or Cisplatin/Pemetrexed in Patients With Advanced Lung Adenocarcinoma With Epidermal Growth Factor Receptor Mutations. J Clin Oncol 2013;DOI: 10.1200/JCO.2012.46.1764.
U.S. GILOTRIF™ Prescribing Information.
Solca F, Dahl G, Zoephel A, et al. Target binding properties and cellular activity of afatinib (BIBW 2992), an irreversible ErbB family blocker. J Pharmacol Exp Ther 2012;343:342-50.
Reid A, Vidal L, Shaw H, do Bono J. Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu). Eur J Cancer 2007;43:481-9.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim’s culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
Boehringer Ingelheim, 25.09.2015 (tB).