FDA Approves Yervoy
FDA Approves Yervoy for Late-Stage Melanoma
The U.S. Food and Drug
Administration today approved Yervoy (ipilimumab) to treat patients
with late-stage (metastatic) melanoma, the most dangerous type of
skin cancer.
Melanoma is the leading
cause of death from skin disease. An estimated 68,130 new cases of
melanoma were diagnosed in the United States during 2010 and about
8,700 people died from the disease, according to the National
Cancer Institute.
“Late-stage melanoma
is devastating, with very few treatment options for patients, none
of which previously prolonged a patient’s life,” said
Richard Pazdur, M.D., director of the Office of Oncology Drug
Products in the FDA’s Center for Drug Evaluation and
Research. "Yervoy is the first therapy approved by the FDA to
clearly demonstrate that patients with metastatic melanoma live
longer by taking this treatment."
Yervoy is a monoclonal
antibody that blocks a molecule known as cytotoxic T-lymphocyte
antigen or CTLA-4. CTLA-4 may play a role in slowing down or
turning off the body’s immune system, affecting its ability
to fight off cancerous cells. Yervoy may work by allowing the
body’s immune system to recognize, target, and attack cells
in melanoma tumors. The drug is administered intravenously.
Yervoy’s safety and
effectiveness were established in a single
international study of 676 patients with melanoma. All patients in
the study had stopped responding to other FDA-approved or commonly
used treatments for melanoma. In addition, participants had disease
that had spread or that could not be surgically
removed.
The study was designed to
measure overall survival, the length of time from when this
treatment started until a patient's death. The randomly assigned
patients received Yervoy plus an experimental tumor vaccine called
gp100, Yervoy alone, or the vaccine alone.
Those who received the
combination of Yervoy plus the vaccine or Yervoy alone lived an
average of about 10 months, while those who received only the
experimental vaccine lived an average of 6.5 months.
Common side effects that can result from autoimmune
reactions associated with Yervoy use include fatigue, diarrhea,
skin rash, endocrine deficiencies (gland or hormone), and
inflammation of the intestines (colitis). Severe
to fatal autoimmune reactions were seen in 12.9 percent of patients
treated with Yervoy. When severe
side effects occurred, Yervoy was stopped and corticosteroid
treatment was started. Not all patients responded to this
treatment. Patients who did respond in some cases did not see any
improvement for several weeks.
Due to the unusual and
severe side effects associated with Yervoy, the therapy is being
approved with a Risk Evaluation and Mitigation Strategy to inform
health care professionals about these serious risks. A medication
guide will also be provided to patients to inform them about the
therapy's potential side effects.
Yervoy is marketed by New
York City-based Bristol-Myers Squibb.
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Posted: March 2011
Related articles
- FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma - July 24, 2017
- FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery - October 28, 2015
- Bristol-Myers Squibb Announces that the U.S. Food and Drug Administration Has Extended the Review Timeline for the Ipilimumab Biologics License Application - November 2, 2010
- Ipilimumab Receives FDA Priority Review Designation for Adult Patients with Previously Treated Advanced Melanoma - August 18, 2010
Yervoy (ipilimumab) FDA Approval History
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