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Treatment for metastatic melanoma recieves CHMP positive opinion


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.

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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 2,444 patients in 386 clinical centres in Europe through our Expanded Access/Compassionate Use Programme.”

Bristol-Myers Squibb

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