FDA Approves Expanded Use for Melanoma Drug
THURSDAY, Oct. 29, 2015 (HealthDay News) -- The melanoma drug Yervoy (ipilimumab) can now be used to reduce the risk of the deadly skin cancer returning after surgery, the U.S. Food and Drug Administration said Thursday.
The expanded use of this intravenous drug is an adjunct therapy for patients with stage 3 melanoma, in which the cancer has reached one or more lymph nodes. Patients with this stage of melanoma typically have surgery to remove melanoma skin tumors and nearby lymph nodes, according to an FDA news release.
Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin cancer.
The "approval of Yervoy extends its use to patients who are at high risk of developing recurrence of melanoma after surgery," Dr. Richard Pazdur, director of the FDA's Office of Hematology and Oncology Products at the Center for Drug Evaluation and Research, said in the news release.
"This new use of the drug in earlier stages of the disease builds on our understanding of the immune system's interaction with cancer," he added.
Yervoy was first approved by the FDA in 2011 to treat late-stage melanoma that cannot be removed with surgery.
The expanded approval is based on a study of 951 patients with stage 3 melanoma who had their cancer removed during surgery. The cancer returned an average of 26 months after surgery in 49 percent of patients who took Yervoy, compared with 62 percent of those given a placebo. The cancer returned within 17 months, on average, among those who took a placebo, the study found.
Yervoy helps the body's immune system recognize and attack cells in melanoma tumors, the agency said.
Common side effects of Yervoy included rash, diarrhea, nausea, fatigue, itching, headache and weight loss. 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.
Yervoy, made by Bristol-Myers Squibb, carries a boxed warning and will include a medication guide to inform patients about potentially severe side effects.
On Tuesday, the FDA approved a first-of-a-kind therapy called Imlygic (talimogene laherparepvec) for melanoma. It's a genetically engineered cold sore virus that "blows up" melanoma tumors.
The U.S. National Cancer Institute estimates that about 74,000 new cases of melanoma will be diagnosed and there will be nearly 10,000 deaths from the disease this year in the United States.
SOURCE: U.S. Food and Drug Administration, news release, Oct. 29, 2015
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