NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) said Thursday that the National Institute of Health and Clinical Excellence has decided to recommend YERVOY (ipilimumab), which is approved in the European Union for the treatment of previously-treated metastatic (advanced) melanoma, within the Final Appraisal Determination. The decision will enable eligible patients in England and Wales to routinely access treatment with YERVOY through the National Health Services.
Metastatic melanoma is the deadliest form of skin cancer with an average life expectancy of just six to nine months and a one-year mortality rate of 75%. YERVOY is the only approved treatment for metastatic melanoma to deliver a durable long-term survival benefit at two years for 24 percent of patients.
In the pivotal study, which included more than 4.5 years of follow up, median overall survival was 10 months for YERVOY and 6 months for the gp100 control arm. Five-year follow up results from three Phase 2 exploratory studies were recently presented during the European Society of Medical Oncology congress, adding to the growing body of long-term survival data for YERVOY in metastatic melanoma.
Overall, the types of adverse events attributed to YERVOY are generally mechanism (immune)- based. YERVOY can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation.
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