(BPT) – We depend on our immune systems to ward off colds and viruses and to keep us healthy. But did you know that your immune system can also play a role in fighting cancer? Stimulating the immune system to fight cancer is one of the more recent advances in cancer research.-

The immune system is your body’s natural defense, helping to protect you from disease. When it is working normally, a group of cells called-T cells-seek out harmful cells and get rid of them. However, in some cases, cancer cells can evade the immune system and your body may need help in fighting these cells.

Immunotherapy & metastatic melanoma

Immunotherapy is a type of treatment that works by stimulating people’s own immune systems to fight the disease. “The immune system is the body’s natural defense and most effective tool for recognizing and fighting disease, which is why immunotherapies offer an exciting approach to fighting some cancers,” said Asim Amin, M.D., co-director of the immunotherapy program at the Levine Cancer Institute in Charlotte, NC.

In the case of metastatic melanoma, the deadliest form of skin cancer, Yervoy® (ipilimumab) is an immunotherapy that may be used to treat the disease. Yervoy is approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients with-melanoma that has spread (metastatic) or-cannot be removed through surgery (unresectable). Yervoy does not kill melanoma directly. It is thought to boost the body’s immune system. It will not work in all patients and may affect healthy cells, too, which could result in serious side effects in many parts of the body. Some of these side effects may lead to death.

“After being diagnosed with metastatic melanoma, it was important that I have a discussion with my doctor to understand what treatment options might be available to me,” said Rick Wilkey of Newport Beach, CA. “My doctor reviewed the options with me and explained that Yervoy is designed to work with my own immune system to fight cancer. Based on our discussion, we decided that Yervoy was the most appropriate treatment for me.”

Long-term survival in some patients

Clinical trial results have shown that some Yervoy patients lived substantially longer than patients who did not receive Yervoy.

In a phase III clinical trial, an estimated 46 percent of patients taking Yervoy alone were alive at one year versus 25 percent of patients taking an experimental drug alone. At two years, 24 percent of patients taking Yervoy alone were alive versus 14 percent taking an experimental drug alone. Patients treated with Yervoy lived a median of 10 months compared to a median of six months for those who were treated with an experimental drug alone.

Of the 676 patients in this trial, 137 patients (20 percent) received Yervoy alone, 136 patients (20 percent) received another experimental drug alone, and 403 patients (60 percent) received both treatments. In the trial, patients were previously treated with one or more of the following: aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin. The primary goal was to measure how long patients lived with Yervoy in combination with the experimental drug compared to the experimental drug alone. The study results showed that treatment with Yervoy decreased the risk of death by about one third compared to patients who received the experimental drug. Individual results will vary. It is important to ask your doctor if Yervoy is right for you.

The serious side effects of Yervoy may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes. In addition to the serious side effects, the most common side effects of Yervoy are tiredness, diarrhea, itching, and rash.

These side effects are most likely to begin during treatment; however, side effects can show up months after the last infusion. Healthcare providers should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with Yervoy. The oncologist may decide to delay or stop Yervoy.

Patients should call their healthcare provider if they have any signs or symptoms or they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Patients should not try to treat symptoms themselves.

These are not all of the possible side effects of Yervoy. Please see the Important Safety Information below for additional information.

Talk to your healthcare provider about any questions you may have about your health or Yervoy. To learn more, visit www.yervoy.com.

Important Safety Information

Yervoy (ipilimumab) can cause serious side effects in many parts of your body which can lead to death. These serious side effects may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes.

These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion. 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.

Call your healthcare provider if you have any signs or symptoms or 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.

Serious side effects may include:

Inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines. Signs and symptoms of colitis may include:diarrhea (loose stools) or more bowel movements than usualblood in your stools or dark, tarry, sticky stoolsstomach pain (abdominal pain) or tendernessInflammation of the liver (hepatitis) that can lead to liver failure. Signs and symptoms of hepatitis may include:yellowing of your skin or the whites of your eyesdark urine (tea colored)nausea or vomitingpain on the right side of your stomachbleeding or bruise more easily than normalInflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis). Signs and symptoms of severe skin reactions may include:skin rash with or without itchingsores in your mouthyour skin blisters and/or peelsInflammation of the nerves that can lead to paralysis. Symptoms of nerve problems may include:unusual weakness of legs, arms, or facenumbness or tingling in hands or feetInflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work. Signs and symptoms that your glands are not working properly may include:persistent or unusual headachesunusual sluggishness, feeling cold all the time, or weight gainchanges in mood or behavior such as decreased sex drive, irritability, or forgetfulnessdizziness or faintingInflammation of the eyes. Symptoms may include:blurry vision, double vision, or other vision problemseye pain or redness
Pregnancy and Nursing:

Tell your healthcare provider if you are pregnant or plan to become pregnant. Yervoy (ipilimumab) may cause stillbirth, premature delivery, and/or death of your unborn baby. Before starting Yervoy, tell your healthcare provider if you are breast-feeding. It is advised that nursing mothers do not breast feed while taking Yervoy.
Tell your healthcare provider about:

Your health problems if you:have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis.had an organ transplant, such as a kidney transplanthave liver damage from diseases or drugshave any other medical conditionsAll the medicines you take including:all prescription and non-prescription medicinessteroids or other medicines that lower your immune responsevitaminsherbal supplementsYou should not start a new medicine before you talk with your healthcare provider who prescribes you Yervoy.

Most Common Side Effects:
The most common side effects of Yervoy include: tiredness, diarrhea, itching, and rash.

These are not all of the possible side effects of Yervoy. If you have any questions about your health or medicines, talk to your healthcare provider.

Please visit www.yervoy.com for U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for Yervoy.