<0> Bristol-Myers Squibb CompanySarah Koenig, 609-252-4145orJohn Elicker, 609-252-4611 </0>
(NYSE: BMY) is pleased to announce that today the (NICE)has decided to recommendYERVOY (ipilimumab), which is approved in the European Union for the treatment of previously-treated metastatic (advanced) melanoma, within the Final Appraisal Determination (FAD). This important decision will enable eligible patients in England and Wales to routinely access treatment with YERVOY through the National Health Services (NHS).
“Today’s decision is very welcome news and marks a major milestone in the treatment of advanced melanoma,” said Dr. Paul Lorigan, Senior Lecturer in Medical Oncology, the Christie NHS Foundation Trust. “Ipilimumab’s potential to provide a long-term survival benefit in some patients makes it an important treatment option and represents a genuine step change in the management of this disease.”
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 (95% CI: 8.0-13.8) for YERVOY and 6 months (95% CI: 5.5-8.7) 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 (September 12 – October 2), adding to the growing body of long-term survival data for YERVOY in metastatic melanoma.
Overall, the types of adverse events (AEs) 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. Adverse events associated with YERVOY are managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.
“Bristol-Myers Squibb is committed to leading advances in immuno-oncology, a field that is focused on harnessing the immune system to fight cancer and one that is increasingly recognized as a fourth pillar of the cancer-treatment platform,” said Beatrice Cazala, executive vice president, commercial operations, Bristol-Myers Squibb. “YERVOY, the first-approved compound from our immuno-oncology pipeline, exemplifies how this type of medical innovation can address a significant unmet clinical need. We are pleased that our close collaboration with NICE on this appraisal over the past year has resulted in an outcome that is in the best interest of patients. Today’s decision supports the UK government’s statement that access to innovative medicines is a key driver for better patient outcomes.”
The NICE approval follows the provision of access to treatment with YERVOY for previously-treated advanced melanoma patients in an increasing number of European countries, including Spain, Germany, Austria, Switzerland, Denmark, Luxembourg, Belgium, Finland, Netherlands, Ireland and Sweden. Bristol-Myers Squibb is working closely with other European authorities to secure further access to YERVOY to address the unmet need.
Historically, common approaches to cancer treatment have included surgery, radiation and chemotherapy or systemic therapy. However, recent advances in the development of immunotherapies have provided further scientific evidence that these novel agents play a role in mediating cancer regression. This, coupled with the increasing use of immunotherapies, has resulted in the recognition of immunotherapy as a fourth pillar of the cancer-treatment platform.
Immuno-oncology, which focuses on the scientific potential of harnessing the unique properties of the immune system to fight cancer, is a prioritized area of research and development at Bristol-Myers Squibb. The Company is committed to leading advances in this important field of research and is exploring a variety of innovative compounds and immunotherapeutic approaches to help address significant unmet medical needs in a broad range of cancers. More information can be found at .
In March 2011, the FDA approved YERVOY 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. It received regulatory approval in the European Union in July 2011 for previously-treated metastatic (advanced) melanoma, making it the first medicine to be licensed in the UK for the treatment of this disease since dacarbazine in 1970. YERVOY is now approved in 41 countries worldwide.
In October, YERVOY received the prestigious Prix Galien USA 2012 Award for Best Biotechnology Product. The Prix Galien Awards were created to honor medical research and pharmacology for outstanding efforts to improve the human condition through approval of innovative treatments and medicines.
YERVOY, which is a recombinant, human monoclonal antibody, is the first-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation.Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses.
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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. For more information about Bristol-Myers Squibb, visit , or follow us on Twitter at .