Cancer researchers and patient advocates are hailing the FDA’s approval of ipilimumab as a major advance not only for the treatment of metastatic melanoma, but also for other novel therapies.
“FDA approval of this drug further strengthens the case for cancer immunotherapy,” said Thomas Gajewski, MD, PhD, of the University of Chicago, who is president of the Society for Immunotherapy of Cancer. “We anticipate other novel immune therapies that will benefit patients with cancer over the coming years.”
Gajewski said the drug, which Bristol-Myers Squibb will market under the name Yervoy, breaks new ground in several ways and that oncologists will have to learn how to use it.
“First, this is a completely new way to treat cancer in the clinic, by blocking a key negative regulator of the anti-tumor immune response,” Gajewski said in a press release. “Second, it is the first drug ever to show improved survival of metastatic melanoma patients.
“And third, we learned that clinical responses to immune therapies such as this one can take time, with patients sometimes showing disease progression prior to regression,” Gajewski said. “This pattern will require significant education of the oncology community that will be utilizing these agents in the near future.”
Tim Turnham, PhD, executive director of the Melanoma Research Foundation, said in an interview with OncLive
that the approval of ipilimumab gives physicians “a new weapon in their arsenal to attack this pernicious cancer.”
Ipilimumab is the first new melanoma drug since interleukin-2 was approved 13 years ago and the prospects for patients taking the new drug are much more attractive, Turnham said.
He said interleukin-2 has “brutal” adverse events that limit the patient population able to take it; the average age of patients using it is about 45 years old. The drug is ineffective in 86% of the patients who take it, with only 4% experiencing a cure and 10% having any response, added Turnham.
He said the response rate in ipilimumab is slightly more than 20% but the adverse events are “manageable.”
“Clearly, we need more drugs, we need to look at combinations of drugs, and we have more work to do,” Turnham said. “I believe this is a big step forward and hopefully an indicator of many more positive steps in the future.”