Boehringer Ingelheim GmbH Logo
2016-03-02 09:40
European Committee for Medicinal Products for Human Use recommends approval of Giotrif® (afatinib) for advanced squamous cell cancer of the lung
  • 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 chemotherapy[1]
    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/Korea Newswire) March 2, 2016 -- Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) (http://goo.gl/fbcEKu) issued a positive opinion (http://goo.gl/iVpYzS) for the approval of Giotrif® (http://goo.gl/ATgrT5) (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 (http://goo.gl/mmMMcq) 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 (http://goo.gl/hk0l2U) 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 (http://goo.gl/hRjIOq)

*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.

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.

For references and notes to editors, please visit:

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

For more information please visit www.boehringer-ingelheim.com

Further Media Channels

www.facebook.com/boehringeringelheim

www.twitter.com/Boehringer

www.youtube.com/user/boehringeringelheim

View source version on businesswire.com: http://www.businesswire.com/news/home/20160229005821/en/
  • Media Contact
  • Boehringer Ingelheim
    Corporate Communications
    Media + PR
    Susanne Granold
    Phone: +49 6132 – 77 93319
    Fax: +49 6132 – 77 6601
    press@boehringer-ingelheim.com
Boehringer Ingelheim GmbH 전체 보도자료 보기
이 뉴스는 기업·기관이 발표한 보도자료 전문입니다. 언론 매체와 블로그는 보도를 목적으로 이 보도자료를 사용할 수 있습니다. 보도자료 등록 안내
Media Contact

Boehringer Ingelheim
Corporate Communications
Media + PR
Susanne Granold
Phone: +49 6132 – 77 93319
Fax: +49 6132 – 77 6601
press@boehringer-ingelheim.com

이 보도자료 관련 분야

건강  제약  개발  해외

관심 분야 보도자료 구독 방법

가입하면 관심 분야 보도자료를 마이 뉴스와 이메일로 볼 수 있습니다. 스마트폰과 RSS로도 가능합니다.

보도자료 배포 서비스 안내

뉴스와이어는 4천여개 언론매체에서 일하는 1만7천여명의 기자에 보도자료를 배포해 언론이 보도할 수 있게 합니다.

해외 보도자료 배포 안내
비즈니스와이어와 제휴해 해외 언론에 보도자료를 배포합니다.