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YERVOY (ipilimumab) approved for the treatment of previously treated advanced melanoma in the EU
Date:7/14/2011

Paris, 14 July 2011 Bristol-Myers Squibb today announced that the European Commission has approved YERVOY (ipilimumab) for the treatment of adult patients with previously-treated advanced melanoma.

YERVOY, an innovative immunotherapy, showed long-term survival in the treatment of patients with advanced melanoma in a randomised, double-blind Phase III study published in the New England Journal of Medicine in June 2010.(1) Based on the survival (Kaplan-Meier) curve, the 1 and 2-year estimated survival rates for patients treated with YERVOY were 46% and 24% respectively vs. 25% and 14% in the comparator arm with some patients alive at 3 and 4 years.

"With the approval of YERVOY physicians now have an important new option to offer to patients with metastatic melanoma. This is a chance of not just months but potentially 3 to 4 years of prolonged survival for some patients in the treatment of metastatic melanoma," comments Professor Alexander Eggermont, General Director, Institut Gustave Roussy, Paris, France. "There is hope that YERVOY's novel mode of action, together with the fact that the recommended complete course of treatment with YERVOY (3 mg/kg) includes 4 infusions over 3 months, could potentially change the way we treat patients with previously treated advanced melanoma. It is an example of what can be done through unleashing the power of one's own immune response."

Bristol-Myers Squibb will now work closely with local health authorities to expedite the availability of YERVOY across the European Union. Prior to approval, the Company provided ipilimumab to nearly 3,000 patients throughout Europe through Compassionate Use / Named Patient Programmes. The Company remains committed to helping ensure that appropriate patients who need YERVOY will receive it while the reimbursement process is finalised by the relevant authorities throughout Europe.

Ron Cooper, President Bristol-Myers Squibb Europe, stated: "With an aver
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Contact: Elzbieta Zawislak
elzbieta.zawislak@bms.com
33-615-523-580
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Source:Eurekalert

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