In a clinical trial, median* overall survival among patients receiving YERVOY was 10 months. Treatment with YERVOY decreased the risk of death by about one-third compared to patients who received the experimental drug.
*The median is the middle point at which half of the patients were still alive.
YERVOY will not work for every patient. Individual results will vary. It is important to ask your doctor if YERVOY is right for you.
The YERVOY clinical trial included unresectable or metastatic melanoma patients who were previously treated with one or more of the following: aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin.
Of the 676 patients who participated in this trial: 20% (137 patients) received YERVOY alone, another 20% (136 patients) received another experimental drug alone, and 60% (403 patients) received YERVOY along with the experimental drug.
The major goal of the trial was to measure how long patients lived with YERVOY in combination with the experimental drug compared to the experimental drug alone.
Based on the published results of this study, it is estimated that:
YERVOY can cause serious side effects in many parts of the body which can lead to death. These serious side effects of YERVOY may include intestinal problems (colitis) that can cause tears or holes (perforation) in the intestines; liver problems (hepatitis) that can lead to liver failure; skin problems that can lead to severe skin reaction; nerve problems that can lead to paralysis; hormone gland problems (especially the pituitary, adrenal, and thyroid glands); lung problems (pneumonitis); kidney problems, including nephritis and kidney failure; inflammation of the brain (encephalitis); eye problems; severe infusion reactions; and graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
The most common side effects of YERVOY include: feeling tired, diarrhea, nausea, itching, rash, vomiting, headache, weight loss, fever, decreased appetite, and difficulty falling or staying asleep.
These problems may happen any time during treatment with YERVOY or after you have completed treatment.
Call your healthcare provider if you have any signs or symptoms, or if they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed.
Do not try to treat symptoms yourself. Your healthcare provider should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with YERVOY. Your oncologist may decide to delay or stop YERVOY.
These are not all of the possible side effects of YERVOY. Please see Medication Guide for additional information. If you have any questions about your health or medicines, talk to your healthcare provider.