CHMP recommends label update for Giotrif® with addition of data demonstrating overall survival benefit for patients with EGFR mutation-positive lung cancer

·         European label update includes Phase III data which showed patients whose tumours have the most common EGFR mutation lived more than one year longer when treated with first-line Giotrif® compared to standard chemotherapy (overall survival = secondary endpoint, primary endpoint = progression-free survival)1

·         Giotrif® is the first and only treatment to demonstrate an overall survival benefit independently in two trials for non-small cell lung cancer (NSCLC) patients with the most common EGFR mutation (del19) compared to chemotherapy1

·         Giotrif® is approved in the EU for the treatment of patients with specific types of EGFR mutation-positive NSCLC who have not been treated before with tyrosine kinase inhibitors (TKIs)

Ingelheim, Germany, 19 August 2015, Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for an update to the European label for Giotrif® (afatinib*), strengthening and broadening the efficacy profile based on additional Phase III data. The CHMP recommendation includes data from the LUX-Lung 3 and 6 trials which showed patients whose tumours have the most common EGFR mutation (deletion in exon 19; del19) lived more than one year longer when treated with first-line Giotrif® compared to standard chemotherapy (overall survival; OS = secondary endpoint, progression-free survival; PFS = primary endpoint).1

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, "This update to the European label reinforces the importance of Giotrif® as a targeted treatment for patients with EGFR mutation-positive NSCLC, especially for those whose tumours harbor the most common mutation, del19. Giotrif® is the first and only targeted agent to date to have shown an overall survival benefit for these patients in the first-line setting."

Following CHMP positive opinion, the European prescribing information will now be updated to include additional data from LUX-Lung 3 and LUX-Lung 6. Both studies met the primary endpoint of PFS for patients whose tumours have common EGFR mutations receiving first-line Giotrif®.[i],[ii] In addition to new OS data, updated PFS data from the two trials will also be reflected in the updated European label, as will the significant improvements in lung cancer-related symptoms (cough, shortness of breath, pain) and quality of life observed with Giotrif® compared to chemotherapy.1

Adverse events for Giotrif® in the LUX-Lung 3 and 6 trials were as expected with EGFR inhibition and were predictable, manageable and reversible.1,2,3 Diarrhoea and rash/acne were the most frequently reported side effects with Giotrif® therapy.1,2,3

NSCLC is the most common form of lung cancer comprising over 85% of lung cancer cases.[iii],[iv] EGFR mutation-positive NSCLC is a subtype of lung cancer. EGFR mutations are found in 10-15% of Caucasian and 40% of Asian patients with NSCLC.[v] There are different types of EGFR mutations; the most common, which account for 90% of all EGFR mutations being del19 (approx. 50%) and L858R (approx. 40%).2,3 Afatinib, an oral, once daily ErbB family blocker, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under brand names: Giotrif® / Gilotrif®).

Notes to Editors

Intended audiences:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About afatinib:

*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with specific types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications.

About Boehringer Ingelheim in Oncology:

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

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