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FDA Approves New Cancer Drug
Carolinas Medical Center Patients, Researchers and Clinicians Helped Assess Drug through Eight Clinical Trials

March 28, 2011

On March 25, the U.S. Food and Drug Administration (FDA) approved the drug ipilimumab [pronounced ipi-li-mu-mab] after successful clinical trials around the world, including eight at Carolinas Medical Center (CMC). Ipilimumab, also known as Yervoy™, is used to treat adult patients with metastatic melanoma (a form of skin cancer that has spread to other parts of the body). The drug is being developed by Bristol-Myers Squibb Company.

In 2009, about 68,000 new cases of melanoma were diagnosed in the U.S., and 8,700 related deaths occurred, according to the American Cancer Society.

“Until now, only two treatment options have been approved by the FDA for advanced melanoma,” said Asim Amin, MD, PhD, Principal Investigator for CMC’s ipilimumab clinical trials. “We are fortunate to have been among the research sites selected to participate in these trials. The opportunity to be able to provide access to cutting-edge options for patients throughout the region has been a very fulfilling experience.”

Blumenthal Cancer Center, part of the newly formed Levine Cancer Institute, has been involved in ipilimumab’s development since early phase clinical trials. Because of this extensive involvement, Blumenthal Cancer Center was selected to be one of the early sites for the “expanded access protocol.” Expanded access protocols (EAP) allow patients who have exhausted other treatment options to be administered a drug when data is considered likely to result in FDA approval. Levine Cancer Institute, through Blumenthal Cancer Center, has been a leader in the development of this drug, with 88 patients treated on the EAP and another 42 patients participating in other clinical trials evaluating ipilimumab.

“The opportunity to offer novel agents like ipilimumab improves the quality of care while providing hope for our patients with cancer. We have enrolled patients from the entire Southeast region on the EAP,” said Steven A. Limentani, MD, Associate Medical Director of Blumenthal Cancer Center, who leads the Center’s clinical trials program. “We are grateful to be able to provide leadership to our colleagues in the development of new and exciting standards that will change the outcomes for patients with cancer. We currently have 242 treatment trials open for patients with both adult and pediatric cancers and continue to work hard on our mission to improve the quality of life and outcome for our patients.”

Ipilimumab works by helping the body develop a stronger immune response against cancer cells. This type of immunotherapy is the first of its kind developed for melanoma and the first new melanoma drug to gain FDA approval in 13 years. For more information on the clinical components and effects of the drug, please refer to Bristol-Myers’ press release.

Derek Raghavan, MD, PhD, incoming President of the Levine Cancer Institute, said, “It is not enough to provide conventional treatments to patients — providing the best patient care increasingly means offering patients access to clinical trials and participating in research that will lead to the development of new treatments.”

The Institute’s mission is to build upon earlier research efforts at CMC to facilitate further innovations in cancer treatment and to work closely with Carolinas HealthCare System’s affiliated care facilities to enhance the quality and convenience of cancer care. As the Institute expands its activities, Dr. Raghavan anticipates “participating in even more clinical trials to bring advances in cancer care to patients more quickly.”

About Bristol-Myers Squibb
Bristol-Myers Squibb (NYSE: BMY) 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 www.bms.com or follow us on Twitter at www.twitter.com/bmsnews.

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