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Positive NICE decision on YERVOY™ (ipilimumab), the first treatment for advanced melanoma to be licensed in the UK for over 30 years

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Decision paves the way for patients in England and Wales to access the first treatment licensed in the UK to demonstrate improved survival for patients with advanced melanoma

Uxbridge, Middlesex (PRWEB UK) 2 November 2012

Today, Bristol-Myers Squibb is pleased to welcome the decision by The National Institute for Health and Clinical Excellence (NICE) to recommend Yervoy (ipilimumab) for the treatment of previously-treated advanced (unresectable or metastatic) melanoma within the Final Appraisal Determination (FAD).1 This landmark announcement will enable patients in England and Wales suffering from this terminal illness to routinely access treatment with ipilimumab - the first treatment to demonstrate improved survival for patients with advanced melanoma and the first medicine to be licensed in the UK for the treatment of this disease since dacarbazine in the 1970s.2 Bristol-Myers Squibb have collaborated closely with NICE over the past year and the Company is pleased to have met all the clinical and economic requirements needed to reach today's positive recommendation.

“Today's decision is very welcome news and marks a major milestone in the treatment of advanced melanoma,” said Dr. Paul Lorigan, Senior Lecturer in Medical Oncology, the Christie NHS Foundation Trust. “Ipilimumab's potential to provide a long-term survival benefit in some patients makes it an important treatment option and represents a genuine step change in the management of this disease.”

Within its appraisal NICE acknowledged that ipilimumab represented a step-change in the treatment of advanced melanoma, a generally fatal disease with a median overall survival of just 6 to 9 months.3 In ipilimumab's pivotal Phase III clinical trial, published in The New England Journal of Medicine, 46% (63 people out of 137) of patients were still alive at one year in the ipilimumab arm and 25% (34 people out of 136) in the comparator arm, a vaccine called gp100. The median overall survival was 10.1 months among patients receiving ipilimumab alone, compared to 6.4 months among patients receiving gp100 alone.4 In some patients treated with ipilimumab long-term survival has been observed, with over 4.5 years of follow-up.5 The safety profile of ipilimumab is considered to be related to its mechanism of action as an immunotherapy. Immune-related adverse reactions, which can be severe or life threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. Early diagnosis and appropriate management of adverse events using established product-specific guidelines are essential to minimise complications.

Commenting on NICE's decision, Gill Nuttall, Factor 50, said “Today's decision by NICE is very welcome news for patients with advanced melanoma, who have waited such a long time for any new treatment options that have the potential to extend life. The important thing now will be for positive guidance to be implemented as soon as possible so that suitable patients can be given a chance to benefit from this treatment.”

Ipilimumab is a fully human monoclonal antibody that works in a new way: by stimulating the body's own immune system to fight melanoma. Around 12,800 people in the UK are diagnosed with melanoma each year and, although the majority of skin cancers are treatable, this disease still kills over 2,200 people in the UK each year.6 Each day more than two young adults aged 15-34 in the UK are diagnosed with malignant melanoma.6 Over the last 30 years, the rate of melanoma in the UK has risen faster than any of the top 10 cancers in males and females and more average years of life are lost from melanoma than in many other cancers (approximately 22).7

Amadou Diarra, European Vice-President and General Manager, Bristol-Myers Squibb UK & Ireland, said, “Bristol-Myers Squibb is committed to leading advances in immuno-oncology. Recent developments in this area have provided further scientific evidence that these novel agents play a role in mediating cancer regression. This, coupled with the growing use of immunotherapies, has resulted in an increasing recognition of these medicines as a fourth pillar of the cancer-treatment platform. Ipilimumab's mechanism of action and its potential for long term survival in some patients, represents a fine example of medical innovation tackling a significant unmet clinical need. The Government has stated that access to innovative medicines is a key driver for better patient outcomes and today's decision from NICE supports this.”

NOTES TO EDITORS

About ipilimumab

Ipilimumab is a fully human monoclonal antibody that works in a new way: by stimulating the body's own immune system to fight cancer.

In July 2011, ipilimumab received a European licence for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. The recommended induction regimen of ipilimumab is 3 mg/kg administered intravenously over a 90-minute period every 3 weeks for a total of 4 doses.8

In the pivotal Phase III clinical trial, published in the New England Journal of Medicine in August 2010, 46% (63 people out of 137) of patients were still alive at one year in the ipilimumab arm and 25% (34 people out of 136) in the comparator, a vaccine called gp100.5 The median overall survival was 10.1 months among patients receiving ipilimumab alone, compared to 6.4 months among patients receiving gp100 alone.4 In some patients treated with ipilimumab long-term survival has been observed, with over 4.5 years of follow-up.5

The safety profile of ipilimumab is considered to be related to its mechanism of action as an immunotherapy. In the pivotal Phase III clinical trial, drug-related adverse events related to the study drug were mostly immune-related adverse events (irAEs), which occurred in approximately 60% of the patients treated with ipilimumab.4 Immune-related adverse events described to date have included gastrointestinal, skin, liver, endocrine or nervous systems.8 The most frequently reported adverse events (≥ 10% of patients) included diarrhoea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite, and abdominal pain.8 The majority were mild to moderate.8 Early diagnosis and appropriate management of adverse events using established product-specific guidelines are essential to minimise complications.8

Ipilimumab in the EU

Bristol-Myers Squibb is in discussion with the authorities across Europe to ensure that eligible patients who need it have access to ipilimumab. Ipilimumab received European approval in July 2011. It is now accessible in Spain, Germany, Austria, Switzerland, Denmark, Luxembourg, Belgium, Finland, Netherlands, Ireland and Sweden. Bristol-Myers Squibb is working closely with other European authorities to secure further access to ipilimumab to address the unmet need.

In May 2012, the Scottish Medicines Consortium (SMC) announced that it would not recommend ipilimumab in Scotland for patients with previously-treated advanced melanoma. The Company now plans to submit a revised application to the SMC.

Bristol-Myers Squibb and immuno-oncology

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Historically, common approaches to cancer treatment have included surgery, radiation and chemotherapy or systemic therapy. However, recent advances in the development of immunotherapies have provided further scientific evidence that these novel agents play a role in mediating cancer regression. This, coupled with the increasing use of immunotherapies, has resulted in the recognition of immunotherapy as a fourth pillar of the cancer-treatment platform.9

Immuno-oncology, which focuses on the scientific potential of harnessing the unique properties of the immune system to fight cancer, is a prioritized area of research and development at Bristol-Myers Squibb. The Company is committed to leading advances in this important field of research and is exploring a variety of innovative compounds and immunotherapeutic approaches to help address significant unmet medical needs in a broad range of cancers.

For further information, please contact:

Reynolds-MacKenzie:                 
Jennifer Garratt                    
Office: 020 7861 2814                
Mobile: 07517 466 242                
Email: jennifer(at)reynoldsmackenzie.com

Bristol-Myers Squibb:
Bridget Mullahy
Office: 01895 523 642
Mobile: 07581 31 3040
Email: bridget.mullahy(at)bms.com

References:
1. NICE Final Appraisal Determination Document. October 2012. Available at: http://www.nice.org.uk. Accessed October 2012
2. Eggermont AM, Robert, C. New drugs in melanoma: It's a whole new world. European Journal of Cancer. 47 (2011) 2150 –2157.
3. Larkin J, Gore M. Malignant Melanoma (metastatic). Clinical Evidence 2008; 08; 1718
4. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 10:1-13
5. Haanen JB et al. Ipilimumab improves overall survival in patients with previously treated, advanced melanoma: Longterm survival results from a phase III trial. Ann Oncol 2010;21(Suppl 8):402
6. Cancer Research UK. Skin cancer – Key facts. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/keyfacts/skin-cancer/. Accessed September 2012
7. Taylor et al. Impact of mortality due to malignant melanoma versus other cancers. J Clin Oncol (Meeting Abstracts) May 2008 vol. 26 no. 15_suppl 20016
8. Yervoy Summary of Product Characteristics. July 2012. Available at:
http://www.medicines.org.uk/EMC/searchresults.aspx?term=yervoy&searchtype=QuickSearch.
9. DeVita, VT., and Rosenberg, MD Two hundred years of cancer research. N Engl J Med. 2012;366:2207-2214

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/11/prweb10084626.htm

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