The U.S. Food and Drug Administration expanded the use of Bristol-Myers Squibb Co’s skin cancer drug, Yervoy, as an additional therapy for patients with advanced melanoma.
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Yervoy can be used to reduce the risk of recurring melanoma in patients who underwent surgery for stage 3 melanoma. Patients at this stage often get surgery as a form a treatment.
The approval came as the result of a recent Phase III study, which showed that more patients with late-stage melanoma, treated with a herpes cold sore virus created to kill tumor cells, had a better response when compared to a different treatment.
“Historically, metastatic melanoma has been a hard disease to treat. Now, a new treatment option based on the combination of two valued immuno-oncology agents demonstrates significant efficacy versus ipilimumab (Yervoy) in metastatic melanoma”, Jedd D. Wolchok, MD, PhD, Chief of the Melanoma and Immunotherapeutics Service in the Department of Medicine and at the Ludwig Center at Memorial Sloan Kettering Cancer Center, said in a news release. While 49% of patients on ipilimumab saw a recurrence by an average of 26 months post-treatment, 62% of those on placebo had their cancer return within 17 months.
Frequently, tumor cells evade the immune system, but Andtbacka says the therapy was developed to retrain the immune system to recognize the melanoma as something that shouldn’t be there.
It seems there are many opportunities ahead to use Imlygic as a starting point for making viral cancer immunotherapy part of the standard of care. The drug can also cause autoimmune disease in the digestive system, liver, skin, nervous system and hormone-producing glands. Pregnant women should not take Yervoy because it can harm the fetus, the FDA said.
The drug label, according to the FDA, includes a boxed warning for the potential for fatal immune-related adverse reactions.
The FDA has approved Imlygic (talimogene laherparepvec), an oncolytic immunotherapy that uses a genetically modified strain of the herpes virus.
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Melanoma is the most aggressive type of skin cancer, and will lead to an estimated 73,870 new cases and 9,940 deaths this year, the National Cancer Institute estimates.
