Navigation Links
FDA Approves New Treatment for a Type of Late-Stage Skin Cancer
Date:3/25/2011

SILVER SPRING, Md., March 25, 2011 /PRNewswire-USNewswire/ --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.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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.

For more information:

FDA: Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Approved Risk Evaluation and Mitigation Strategies (REMS)

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

FDA: Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

NCI: Melanoma

http://www.cancer.gov/cancertopics/types/melanoma

CDC: Skin Cancer

http://www.cdc.gov/cancer/skin/

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Zostavax Vaccine to Prevent Shingles in Individuals 50 to 59 Years of Age
2. FDA Approves Gadavist for Central Nervous System Scans
3. U.S. FDA Approves Bayers Gadavist™ (Gadobutrol) Injection for MRI of the Central Nervous System
4. FDA Approves Device to Maintain Blood Flow During Artery Bypass Brain Surgery
5. FDA Approves BENLYSTA® for Lupus in Breakthrough for Millions of Sufferers
6. FDA Approves Revised Alphanate® Labeling to Include Reduced Infectivity of an Experimental Model Agent for vCJD
7. UPDATE: FDA Approves New Drug to Treat Chronic Obstructive Pulmonary Disease
8. FDA Approves New Drug to Treat Chronic Obstructive Pulmonary Disease
9. FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
10. FDA Approves Edarbi to Treat High Blood Pressure
11. FDA Approves EDARBI (azilsartan medoxomil) for the Treatment of Hypertension
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/6/2016)... 2016 Homozygous Familial Hypercholesterolemia (HoFH) ... Global Markets Direct,s latest Pharmaceutical and ... (HoFH) – Pipeline Review, H2 2016, provides ... (HoFH) (Metabolic Disorders) pipeline landscape. Homozygous ... is caused due to mutation from both ...
(Date:12/6/2016)... Dec. 6, 2016 Human Vaccines Market: ... region wise and country wise analysis of the ... manufacturers of human vaccines products, raw material suppliers, ... enter the market. The report provides qualitative ... market. Qualitative analysis comprises market dynamics, trends, product ...
(Date:12/6/2016)... , Dec. 6, 2016  Nearly 30 million ... suffer from the epidemic of diabetes. 1 However, ... persistently elevated glucose levels (hyperglycemia) and significant glucose variability. 2 ... serious complications, including cardiovascular events. If left untreated, hyperglycemia ... and eye disease or blindness. 3 ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... December 07, 2016 , ... One of two inventors from Glen Burnie, ... is painful for her. "This is why the co-inventor and I have designed a ... They then created a prototype of the patent-pending AV-AIR, a device that serves as ...
(Date:12/7/2016)... ... XX, 2016 (PRWEB) (PRWEB) December 07, 2016 , ... Man’s ... Filamentous Dermatitis Associated with Borrelia Infection” reveals that a condition similar ... the prestigious Journal of Veterinary Science & Medical Diagnosis. , Morgellons disease is ...
(Date:12/7/2016)... (PRWEB) , ... December 07, 2016 , ... Facial plastic ... this holiday season by donating a portion of proceeds to two local organizations: North ... Chicago Animal Control & Friends is a team of authorized and trained volunteers ...
(Date:12/7/2016)... , ... December 07, 2016 , ... ... 20 Marketing Campaign Winner in the Folio: Marketing Awards competition. Live From won ... year’s best in pioneering, inventive, and ultimately successful projects undertaken by the media ...
(Date:12/7/2016)... ... December 07, 2016 , ... Gensuite ... Brilliance Awards under the Best New Product Launch category. Gensuite’s entry on their ... experience. , BOC Global Events & Training Group is a professional event and ...
Breaking Medicine News(10 mins):