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