European Committee for Medicinal Products for Human Use recommends approval of Giotrif® (afatini

• In LUX-Lung 8 trial, Giotrif^® (afatinib) significantly improved overall survival and progression-free survival compared to Tarceva^® (erlotinib) in patients with squamous cell carcinoma of the lung whose tumours progressed on or after platinum-based chemotherapy¹
• If approved by the European Commission, afatinib will provide an important new oral treatment option for patients with this difficult-to-treat lung cancer
• Afatinib is already approved in more than 60 countries for the treatment of patients with EGFR mutated non-small cell 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) issued a positive opinion for the approval of Giotrif^® (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy. Afatinib is already approved for the treatment of patients with EGFR mutated non-small cell lung cancer (NSCLC).*

The CHMP positive opinion is based on the results of the head-to-head LUX-Lung 8 trial in patients with SqCC of the lung whose tumours progressed on or after first-line chemotherapy. Afatinib, compared to erlotinib, demonstrated:¹

• Significant delay in progression of lung cancer (PFS, progression-free survival, primary endpoint), reducing the risk of cancer progression by 19%
• Significant improvement in overall survival (OS, key secondary endpoint), reducing the risk of death by 19%
• An improvement in quality of life and control of cancer symptoms

The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects: a higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhoea: 10% vs 2%; grade 3 stomatitis: 4% vs 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs 6%).¹

SqCC of the lung develops in the cells lining the airways and represents approximately 20-30% of NSCLC cases.^2,3 It is associated with a poor prognosis, limited survival and symptoms like cough and dyspnoea; the median OS after diagnosis of advanced SqCC is around one year.^4,5

Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented: “Despite recent advances in the treatment of squamous cell lung cancer, this disease remains challenging to treat. We are pleased to receive this positive opinion from the CHMP for afatinib; not only does it represent the potential availability of the first oral treatment option specifically approved for patients with squamous cell lung cancer, it also confirms the positive profile of afatinib, a second-generation EGFR targeting agent, when compared to a first-generation agent.”

LUX-Lung 8 is part of the afatinib LUX-Lung programme – the largest collection of clinical trials of any EGFR tyrosine kinase inhibitor (TKI), with over 3760 patients across eight studies conducted across the world. The comprehensive programme includes two pivotal studies in the first-line setting, LUX-Lung 3 and 6, as well as two head-to-head studies (LUX-Lung 7 and 8) of afatinib versus first-generation EGFR TKIs. The LUX-Lung programme has involved lung cancer specialists across over 680 sites in 40 countries around the world, reflecting the strong partnership between Boehringer Ingelheim and the lung cancer specialist community.

Afatinib is already approved in over 60 countries for the first-line treatment of EGFR mutation-positive NSCLC*, and recent results from the LUX-Lung 7 trial positively underscored benefits of afatinib versus another first-generation EGFR targeting agent in this indication.⁶ Results of this global Phase IIb head-to-head trial demonstrated afatinib was superior in reducing the risk of lung cancer progression and the risk of treatment failure both by 27% compared to gefitinib.⁶

For more information about the LUX-Lung 8 Trial, please see Professor Jean-Charles Soria’s publication in The Lancet Oncology

*Afatinib is approved in the EU under the brand name Giotrif^® for the first-line treatment of tyrosine kinase inhibitor naïve adult patients with advanced EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information.

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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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http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2016/29_february_2016oncology.htm

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