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Bristol-Myers Squibb Receives CHMP Positive Opinion for YERVOY(TM) (ipilimumab) for Previously-Treated Patients With Metastatic Melanoma
Paris (ots/PRNewswire) - YERVOY (ipilimumab) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with previously-treated unresectable or metastatic melanoma. The European Commission will consider the CHMP's positive opinion in its decision on whether to grant a Marketing Authorisation by August 2011.
"Despite the rising incidence of melanoma across Europe, no new treatment options have been approved in more than a decade. Receiving a positive opinion for YERVOY from the CHMP represents an important milestone for scientific advance in this disease area." said Ron Cooper, President, Bristol-Myers Squibb Europe.
Immunotherapy is an active area of cancer research that could offer a new treatment paradigm, through indirectly targeting the tumour by using the patient's immune system to fight cancer cells.
The CHMP's opinion is based on the currently available data for ipilimumab, including results from a pivotal randomised double-blind Phase III study, published in the New England Journal of Medicine.
"We believe that immune-therapy represents the next era of cancer fighting treatments and we are dedicated to addressing the grave and unmet medical need in melanoma," said Magnus Jaderberg, Chief Medical Officer, Bristol-Myers Squibb Europe. "As part of our commitment we have already provided YERVOY to 2444 patients in 386 clinical centres in Europe through our Expanded Access/Compassionate Use Programme."
If detected early melanoma can be cured, however when the disease has spread to other parts of the body, the ability to treat becomes difficult. In late stages of melanoma, the average survival rate is about 6 months with a 1-year mortality rate of 75%, making it one of the most aggressive forms of cancer.
In Europe, about 67,500 people are diagnosed with melanoma each year. The disease is characterised by a malignant transformation of the skin's pigment-producing cells (melanocytes) in the deep layer of the skin, but also in the middle layer of the eye, the inner ear, and in some internal organs.
About YERVOY(TM) (ipilimumab)
Ipilimumab is a fully human monoclonal antibody against cytotoxic T-lymphocyte antigen-4 (CTLA-4)-antibody. CTLA-4 plays a crucial role in regulating the natural immune response, sending inhibitory signals to T-cells. Ipilimumab blocks the activity of CTLA-4, which allows the natural immune response to react to, and attack, cancer cells.
On 25th March 2011, the US Food and Drug Administration (FDA) approved YERVOY (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma in the US.
About Bristol-Myers Squibb
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.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the European Commission will approve ipilimumab or that ipilimumab will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
 The American Cancer Society. What is Immunotherapy? Available at: http://www.cancer.org/Treatment/TreatmentsandSideEffects/Treatmen tTypes/Immunotherapy/immunotherapy-what-is-immunotherapy. Accessed May 2011.
 Hodi FS et al. Improved Survival with Ipilimumab in Patients with Metastatic Melanoma. N Engl J Med 2010;363(8):711-23.
 The Skin Cancer Foundation. Melanoma. Available at http://www.skincancer.org/Melanoma/. Accessed May 2011.
 Korn E et al. Meta-analysis of Phase II Cooperative Group Trials in Metastatic Stage IV Melanoma to Determine Progression-Free and Overall Survival Benchmarks for Future Phase 2 Trials. J Clin Oncol 2008;26:527-534.
 European Cancer Observatory. Cancer: Melanoma of skin. Available at http://eu-cancer.iarc.fr/cancer-11-melanoma-of-skin.html,en. Accessed May 2011.
 PubMed Health. Melanoma. Available at http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001853/. Accessed May 2011.
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Media Contact: Elzbieta Zawislak,