Business Wire

European Committee for Medicinal Products for Human Use recommends approval of Giotrif® (afatinib) for advanced squamous cell cancer of the lung

Del

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.

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

Contact information

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 14:00Pressemelding

Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a

Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 13:13Pressemelding

Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform

Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 12:00Pressemelding

Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-

JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 12:00Pressemelding

NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.

Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 11:01Pressemelding

Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also

Norsk Titanium Collaborates with QuesTek Innovations LLC17.7.2018 11:00Pressemelding

Norsk Titanium (Norsk) and QuesTek Innovations LLC (QuesTek) announce a collaborative effort to test novel titanium alloys for applicability in additive manufacturing processes. As part of this collaboration, the companies are evaluating a QuesTek-designed titanium alloy using Norsk’s Rapid Plasma Deposition™ (RPD™) process. Preliminary evaluation of the alloy is complete and Norsk has manufactured initial test specimens. The test program will characterize the alloy microstructure, provide initial material properties, and will confirm QuesTek’s Ti alloy performance using Norsk’s proven production process. QuesTek’s patented titanium alloy has previously demonstrated approximately 15% greater strength and improved ductility over traditional Ti-6Al-4V in both wire-based Electron Beam Additive Manufacturing and traditional casting processes. "We are excited to be working closely with Norsk Titanium’s business and technical team to evaluate our alloy in their proven process. Based on our i