Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

People with an Advanced Form of Thyroid Cancer Now Able to Benefit From Lenvima® (lenvatinib) in Scotland


News provided by

Eisai

09 Oct, 2016, 23:01 GMT

Share this article

Share toX

Share this article

Share toX

HATFIELD, England, October 10, 2016 /PRNewswire/ --

Patients in England denied access to lenvatinib due to administrative delays  

The Scottish Medicines Consortium (SMC) approves the use of Lenvima® (lenvatinib) for people with radioactive iodine refractory differentiated thyroid cancer (RAI-R DTC) in Scotland.[1] Advanced thyroid cancer has a poor prognosis with a 10-year survival rate of around 15%[2] and lenvatinib represents a significant step forward for patients in Scotland.

Lenvatinib is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary, follicular, Hürthle cell) thyroid carcinoma, refractory to radioactive iodine
(RAI-R DTC).[3]

The availability of lenvatinib in Scotland contrasts with England, where the treatment may not be available to people with RAI-R DTC for a further two years. In July this year, NICE confirmed that guidance on the use of lenvatinib will not be published until at least 2018. Lenvatinib received a marketing authorisation from the European Commission more than a year ago, in May 2015.[1]

NHS England appears to be blocking patient access to lenvatinib, despite the clear clinical need. Eisai is aware of scores of individual funding requests made by clinicians for the use of lenvatinib in eligible patients, and no patient has yet received the treatment.

Thyroid cancer incidence rates have increased in the UK over the past few decades,[4] with 3,241 new cases diagnosed in 2013.[4] Standard treatment for early and locally spread differentiated thyroid cancer is surgery to remove the thyroid gland, followed by radioactive iodine ablation (radioiodine) and endocrine therapy.[5],[6] However approximately 5% of patients fail to respond to this treatment and develop RAI-R DTC.[7] In 2013 there were approximately 160 people in the UK with RAI-R DTC.[4],[7]

"The Beatson Oncology Centre participated in the phase 3 clinical trial with lenvatinib in patients with advanced thyroid cancers which were refractory to radio iodine. The SELECT study showed that treatment with lenvatinib can significantly delay the progression of advanced thyroid cancer. In addition lenvatinib showed high objective response rates indicating that the treatment is likely to be effective in a large number of patients with the condition. Both of these factors are of great importance to patients and their families. The announcement of the approval of the use of lenvatinib for patients with advanced thyroid cancer is really positive news and gives us a choice of drugs in this difficult to treat condition," comments Dr Nick Reed, Consultant Clinical Oncologist, Beatson Oncology Centre, Glasgow and investigator on the SELECT trial.

"There are a small number of people who live with thyroid cancer that has stopped responding to radioiodine. Until recently there have been very few effective treatment options available. I am sure that both patients, and the clinicians looking after them, will welcome the decision of the SMC to allow lenvatinib as a first line treatment option," comments Dr Leslie Samuel, Macmillan Consultant Oncologist at Aberdeen Royal Infirmary.

In the SELECT study, Lenvatinib demonstrates significantly prolonged progression-free survival (PFS) in RAI-R DTC versus placebo.[8] Lenvatinib shows a median 18.3 months PFS versus 3.6 months for placebo (hazard ratio [HR] 0.21; 99% confidence interval 0.14-0.31, p<0.001).[8] In addition, the study underlines the rapid response of lenvatinib, with a median time to first objective response of two months and objective response rate versus placebo of 64.8% versus 1.5%; p<0.001.[8] For lenvatinib, the most common treatment related adverse events of any grade were hypertension, diarrhoea, fatigue, decreased appetite, decreased weight, and nausea.[8] The New England Journal of Medicine published SELECT study, a randomised, double-blind, multicentre trial for people with progressive radioactive iodine refractory differentiated thyroid cancer (n=392).[8]

In August, the European Commission issued a marketing authorisation for lenvatinib in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF)-targeted therapy.[9] Lenvatinib was granted an accelerated assessment by the European Medicines Agency in October 2015.

"The availability of lenvatinib is clearly a positive step forward for people in Scotland who live with this rare form of thyroid cancer. We are encouraged that the SMC has moved quickly to ensure people in Scotland will be able to access such a treatment that patients respond to rapidly with a proven progression-free survival benefit. However, Eisai remains extremely disappointed and desperately unhappy by the total lack of any flexibility shown by NHS England in providing earlier access to patients in England than is currently anticipated. In their approval, the SMC have ruled that lenvatinib is both clinically and cost effective. This proves unequivocally that the process in England is seriously flawed," comments Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA.

Lenvatinib is an oral multikinase inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor-alpha, and RET and KIT proto-oncogenes.[10],[11] Lenvatinib has been approved for the treatment of radioiodine refractory differentiated thyroid cancer in the United States, European Union, Russia, Switzerland, Australia, Canada, Israel, Singapore, Japan, South Korea and Brazil.

The development of lenvatinib underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to the therapeutic area of oncology and the unmet medical needs of patients and their families.

Notes to Editors 

Lenvima® (lenvatinib)  

Eisai is currently conducting clinical studies of lenvatinib in several types of cancer including hepatocellular carcinoma (phase III), renal cell carcinoma (phase II), non-small cell lung cancer (phase II) and endometrial cancer (phase II).

About SELECT[8]

SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) is a multicentre, randomised, double-blind, placebo-controlled phase III study of patients with radioiodine-refractory differentiated thyroid cancer, treated with once-daily, oral lenvatinib (24mg).[8] The study enrolled 392 patients in over 100 sites in Europe, Americas, Asia, and Australia.[8]

About Thyroid Cancer 

Thyroid cancer forms in the tissues of the thyroid gland, located at the base of the throat near the trachea.[12] Thyroid cancer affects more than 52,000 people in Europe each year.[13]

About Eisai Co., Ltd. 

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

References  

1. Scottish Medicines Consortium Decision.
2. Desphande H, Gettinger S, et al. Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer. Core Evidence, 2009;4:43-8
3. SPC Lenvima (lenvatinib) (updated June 2015). Available at: http://www.medicines.org.uk/emc/medicine/30412. Accessed September 2016
4. Cancer Research UK. Thyroid Cancer Incidence Statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/thyroid/incidence/uk-thyroid-cancer-incidence-statistics Accessed: September 2016
5. Antonelli A et al. Current Genomics 2001;12:626-31
6. Sacks W, Braunstein G. Clinically meaningful endpoints in the evolving treatment paradigm for radioactive iodine-refractory differentiated thyroid cancer. Expert Review of Endocrinology & Metabolism. Early online, 1-8 (2015).
7. Xing MM, Haugen B, et al. Progress in molecular-based management of differentiated thyroid cancer. The Lancet 2013; 381: 1058-698.
8. Schlumberger M, Tahara M, et al. Lenvatinib versus placebo in radioiodine refractory differentiated thyroid cancer. NEJM, 2015; 372: 621-630. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1406470 Accessed: October 2016
9. SPC Kisplyx (lenvatinib), (updated September 2016). Available at: https://www.medicines.org.uk/emc/medicine/32335. Accessed: October 2016
10. Matsui J, Yamamoto Y, et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. International Journal of Cancer 2008;122:664-671
11. Okamoto K, Ikemori-Kawada M, et al. Distinct Binding Mode of Multikinase Inhibitor Lenvatinib Revealed by Biochemical Characterization. ACS Medicinal Chemistry Letter 2014;6:89-94
12. National Cancer Institute at the National Institute of Health. Thyroid Cancer Treatment. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/Patient/page1/AllPages#1 Accessed: October 2016
13. EUCAN 2015. Thyroid Cancer. Available at: http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=35 . Accessed: October 2016

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.