Manufacturer / Distributor:
Bristol-Myers Squibb Eeig
YERVOY® is available by prescription only
Mode of Action (MOA):
Ipilimumab is a new anticancer drug. It works as an antibody by interacting with the cytotoxic lymphocyte antigen 4
(CTLA-4), thus causing the death of tumor cells.
YERVOY® is indicated for the treatment of patients with unresectable or metastatic melanoma after failure of at
least one line of treatment. Scientists are also working on implementing the drug in the treatment of lung cancer
and prostate cancer. In the last debates held in the presence of a representative of the National League against
Cancer, the marketer of drug offered promising perspective in its use against advanced
A Phase 3 study conducted in patients with metastatic melanoma who have received at least one treatment line showed
an overall 1-year survival of 46% in patients treated with ipilimumab. The most frequently reported side effects
are diarrhea, skin reactions and other potentially severe immunological reactions that reflect the mode of action
of the drug. This drug is currently the subject of a first-line treatment of metastatic melanoma, as well as other
cancers, in combination with other anticancer drugs.
The use of Ipilimumab seems favorable in Europe. The French Agency for the Safety of Health Products (AFSSaPS) said
that the European Medicines Agency (EMA) issued a positive opinion on May 19, 2011 for the granting of a marketing
authorization for the drug to the laboratory Bristol-Myers Squibb Pharma EEIG. A risk management plan will be
implemented as part of the placing on the market, particularly to monitor the immunological adverse ractions of the
medication on patients.
YERVOY is given by infusion into a vein (intravenous, IV).
YERVOY is recommenmded to be taken at a dose of 3 mg / kg by intravenous infusion over a 90 minute period, every 3
weeks, for a total of 4 doses. Except in case of intolerance or complications, it is highly recommended that
patients complete the entire therapy, regardless of development of new lesions or growth of existing lesions. The
response of the tumor to the drug should be assessed at the end of the therapy.
Ipilimumab may cause damage to the liver and the tyrpid gland. Thyroid and liver functions should be evaluated
prior to initiation of treatment with YERVOY and before each administration. In addition, any signs or symptoms of
immunological side effects, such as diarrhea and colitis, must be assessed during the treatment with the
Common side effects of Ipilimumab include:
Ipilimumab may cause severe or life-threatening side effects such as fainting; inflammation of the intestine;
damage or inflammation of the liver, inflammation of the skin, and damage to the nerves: paralysis, loss of ability
to move all or part of the body. See your oncologist immediately I you experience any of the following
Eye pain or
Blurred and/or double
Diarrhea or frequent
Bloody or black, tarry,
Stomach pain or
Yellowing of the skin
Easy bruising or
Skin rash which can be
Blistering or peeling
Sores in the
Unusual weakness of the
legs, arms, or face
Numbness or tingling in
the hands or feet
Feeling cold all the
"FDA Rubber-Stamps Bristol-Myers Squibb’s Melanoma
mAb". Genetic Engineering & Biotechnology News. 2011-03-28. Retrieved
Marc (2014). Targeted Therapies in Cancer. Hauppauge , NY:
Nova Sciences Publishers. ISBN 978-1-63321-687-7.
"STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL -
ipilimumab" (Press release). American Medical Association (AMA). Retrieved
trial number NCT00527735 at ClinicalTrials.gov Phase II Study for Previously Untreated Subjects With
Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
Ribas (28 June 2012). "Tumor immunotherapy directed at PD-1". New England
Journal of Medicine 366 (26): 2517–9. doi:10.1056/nejme1205943.
trial number NCT01524991 at ClinicalTrials.gov
trial number NCT00323882 at ClinicalTrials.gov Phase I/II Study of MDX-010 in Patients With
Metastatic Hormone-Refractory Prostate Cancer (MDX010-21) (COMPLETED)
- Breakthrough of the Year: Cancer Immunotherapy, Science 20 December
2013, Vol. 342 no. 6165 pp. 1432-1433, DOI: 10.1126/science.342.6165.1432, Jennifer Couzin-Frankel
E (2011-03-25). "FDA approves new treatment for a type of late-stage skin
cancer" (Press release). U.S. Food and Drug Administration (FDA). Retrieved
Andrew (2011-03-25). "Approval for Drug That Treats Melanoma".
The New York Times. Retrieved 2011-03-27.
Notice of Decision for YERVOY
"Bristol-Myers Squibb Receives Positive Decision from
National Institute of Health and Clinical Excellence (NICE) for YERVOY® (ipilimumab)" (Press
release). November 1, 2012. Retrieved December 17, 2012.