What is it? Overview Usage Side Effects and Warnings

What is Ipilimumab?

Ipilimumab (sold as Yervoy) was approved for metastatic melanoma treatment by the FDA March 20111 and is a promising example of cancer immunotherapy. The drug is classified as a biotherapy, not a chemotherapy. Where chemotherapy kills dividing cells and biotherapy bolsters the body’s immune system to fight the disease. Ipilimumab was developed from research by Dr. James Allison in the 1990s2 to increase the body’s immune fight against cancer tumors by interfering with a mechanism tumors used to evade natural attack. By blocking the signals limiting immune response, the body is enabled to attack the tumors. The results of the Phase III trials showed that median overall survival was 10 months for patients treated using Yervoy, compared with six months for treatment using...

Ipilimumab (Yervoy) is given through an IV during an office visit every three weeks for a total of four doses. The recommended does is 3 mg/kg.9 The standard course of treatment costs about $120,000. For patients who showed severe side effects, the recommendation is to cease, use hydrocortisone, and to not try it again. Ipilimumab was approved by the FDA in March 2011, however, the UK National Institute of Clinical Excellence8 did not approve payment for the drug with the reasoning that it helped only 20-30% of the patients live approximately four months longer and the cost of the drug exceeded the perceived benefit. It will be important to follow the research as the drug is tried on other cancers and given to a larger number of patients in the US and other countries.

Ipilimumab (sold as Yervoy) has side effects that come from the activation of T-cells and the body’s immune responses. The most common are side effects are very much like auto-immune disorders and include a number of adverse reactions including diarrhea, rash, fatigue, nausea, vomiting, decreased appetite, and abdominal pain. In the clinical trials, Ipilimumab use was stopped in 10% of the patients due to the severity of the side effects. Ipilimumab side effects varied widely with the test population, and can appear after the drug use is stopped. Sensitive patients were given hydrocortisone to reduce the immune system activity.1,3,4,7,9