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:5/26/2016)... TARE (Transarterial Radio-embolization) Using ... and Overall Decreased Use of Hospital Resource ... specialist healthcare company, has today announced the publication ... of ISPOR (International Society for Pharmacoeconomics and Outcomes ... using yttrium-90 glass microspheres is associated with cost ...
(Date:5/25/2016)... GERMANTOWN, Maryland , May 25, 2016 /PRNewswire/ ... dringenden Bedarf zur Steuerung ... N.V. (NASDAQ: QGEN ; Frankfurt Prime ... Entwicklungsvereinbarung mit Therawis Diagnostics GmbH zur Entwicklung und ... sein. Ein erstes Projekt wird die Entwicklung und ...
(Date:5/25/2016)... As illustrated by the Spring ... the numbers and momentum of cannabis in the US ... billions, more research and development push the sector forward. ... Legal Marijuana Markets Report  from from ArcView Market Research ... the increase in sector is attributed to adult use ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... ... a multitude of activities from daily practices, arts & crafts, discussions, and games ... Amber East-D’Anna and Christy Evans have combined backgrounds in kids’ yoga, collegiate sport ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... ... education and products recently hosted the first PowerWave Instructor Certification Course in Stoughton, ... lead a group of fitness professional through the 8 hour interactive course to ...
(Date:5/26/2016)... (PRWEB) , ... May 26, 2016 , ... A health ... startup, The Dough Bar, has ignited an undeniable buzz in the protein ... doughnut. But not just any doughnut.  These doughnuts are packed with 11 grams of ...
(Date:5/26/2016)... ... 26, 2016 , ... Saint Francis Hospital & Medical Center ... efforts have paid off. Since implementation of these efforts, surgical errors and ... perioperative patient experiences and reduce costly complications. Since implementation in 2011, safety efforts ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... nominations to serve on its Accreditation and Standards Committees and support the ... activities incorporate key process and outcome measures, with the ultimate mission of ...
Breaking Medicine News(10 mins):