08:33 uur 19-08-2015

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

INGELHEIM, Germany–(BUSINESS WIRE)– 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).

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 ®. 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.

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

NSCLC is the most common form of lung cancer comprising over 85% of lung cancer cases. 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. 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%). 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 ®).

*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.

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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.

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