Immunotherapy Drug Receives FDA Approval for Advanced Melanoma

James Allison

James Allison

The US Food and Drug Administration announced in late March that the drug ipilimumab (Yervoy) had been approved for the treatment of patients with metastatic melanoma. It is the first drug ever shown to improve overall survival for patients with advanced melanoma.

Ipilimumab uses an approach known as immunotherapy, which exploits the body’s own immune system to attack cancer. This specific type of immunotherapy, originally known as anti-CTLA-4, was developed in 1996 by Memorial Sloan Kettering immunologist James P. Allison. For more than 20 years, Dr. Allison’s research has focused on the mechanisms that regulate the immunologic responses of T lymphocytes (T cells) with an emphasis on manipulating T cell response in order to develop novel tumor immunotherapy approaches.

Center researchers were also involved in preclinical and clinical studies using ipilimumab, most notably a 2009 phase II multicenter trial led by medical oncologist Jedd D. Wolchok. Dr. Wolchok also led a team in the development of a novel set of tumor-response criteria based on ipilimumab’s unique mechanism of action. (Read more about Dr. Wolchok’s work.)

“The fact that we now have a drug that produces an improvement in overall survival for patients with metastatic melanoma is a significant achievement in a disease that has been so resistant to standard therapies,” Dr. Wolchok says. “It is also a great source of hope for patients as we now build on the success of ipilimumab with novel combination therapies.”

“The success of ipilimumab underscores the importance of basic research to clinical accomplishment,” Dr. Allison adds. “The concept came directly out of our studies on fundamental mechanisms of regulation of T cell responses.”