The Melanoma Research Alliance (MRA) welcomes news that the US Food & Drug Administration (FDA) has expanded the approval of Bristol-Myers Squibb’s (BMS) ipilimumab (Yervoy) to include its use as adjuvant therapy for patients with Stage III melanoma at high risk of recurrence after surgery. While 10 treatments for advanced melanoma have reached the market in the last 5 years, this is the first approved treatment for the adjuvant setting since 2011.
First approved in 2011, ipilimumab is an anti-CTLA-4 inhibitor, a type of immunotherapy known as a checkpoint inhibitor, which helps the body’s own immune system attack cancer cells. The drug blocks the activity of CTLA-4 and activates T cells to help strengthen the immune system. The FDA’s decision was based on the results from a Phase III clinical trial, EORTC 18071.
“The rate at which we’re seeing progress in available treatments for patients with advanced melanoma is truly impressive,” said Robin Davisson, PhD, MRA’s President and CEO-Elect. “There is still a significant amount of research needed to better understand the disease and the available therapies, but today’s announcement from the FDA marks an important step forward.”
Added Louise M. Perkins, PhD, MRA’s Chief Science Officer: “In the 4 years since ipilimumab was approved for advanced melanoma, immunotherapy has rapidly moved to the fore and this latest approval is a testament to just how far we’ve come in a very short time period.”
“The FDA’s expanded approval of this immunotherapy drug is a critical step in our ongoing fight against melanoma and other cancers,” said Debra Black, MRA Co-Founder and Chair of the Board. “We must continue to push research to expand our understanding about this disease and eliminate suffering for more patients.”
MRA is the leading private funder of research into the treatment and cure of melanoma, an often fatal skin cancer when metastasized. Since MRA launched in 2007, both targeted and immune-based therapies have been approved to treat melanoma, drastically changing the outlook for patients with melanoma and other cancers. MRA has funded research for all of these therapies and has invested more than $26 million toward studying immunotherapy.