FDA Approved a Drug that Extends the Lives of Melanoma Patients

Frequent deadly type of skin cancer is melanoma. 1 Melanoma affects young adults and older people. Primarily the cause of melanoma: Over - exposure to the sun's ultraviolet (UV) radiation causing damage to the skin (childhood or adolescents), and especially those with fair skin. Children with freckles at risk to develop melanoma as adults, exposed to ultraviolet sun burn rays. 5 This type of skin cancer involves cells in the skin called melanocytes, outer surface epidermis. 2 Melanocytes give rise to a skin pigment called melanin. "Melanin is responsible for skin and hair color." "Melanoma can appear on normal skin, or it may begin as mole or other area that has changed in appearance. Some moles that are present at birth may develop into melanomas." 3

In 2010, the American Cancer Society reported 68,000 Americans diagnosed with metastatic (Invades other parts of the body. 12) melanoma (disease) and 8,700 related deaths. During the past 30 years, this deadly type of skin cancer has steadily risen, faster than other common cancers.1 According to Scott Woodman, M.D., Ph. D, an instructor in the Department of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center, nearly seven percent of melanomas are non-cutaneous: The disease is diagnosed in the eye, and mucous membranous sites including the rectum, valva, vagina, anus, mouth and nasal sinuses. Most melanomas are diagnosed early, when the curable rate is much higher by surgery alone. 4 The U.S. Food and Drug Administration approved ipilimumab (injectable drug 8) for previous unsuccessful treatment, during late stage (deadly skin cancer) or advanced melanoma. 1

Bristol-Myers Squibb and Medarex developed ipilimumab (brand name Yervoy) for treating melanoma, when other treatment options failed. 6 Ipilimumab binds to culprit CTLA-4 (cytotoxic lymphocyte-associated antigen 4) that suppress the immune system from attacking cancer cells, now able to fight the disease by a man-made monoclonal antibody (7 ): Referred to as immunotherapy. 9 In the American Society of Clinical Oncology and in the England Journal of Medicine (2010), reported during phase three clinical trial (1): "In a trial of 676 melanoma patients, people who received ipilimumab lived 10 months on average, compared to 6 months for people not taking the drug..." Also, the study confirmed ipilimumab more likely kept patients alive, after two years. The drug has proven to be successful for treating first - time melanoma patients, according to a recent trial study. 6 Dr. Asim Amin, co-director of immunotherapy at CMC's (Carolinas Medical Center) Bluementhal Cancer Center said regarding ipilimumab: "We've treated individuals 80 years old with good response... This gives us another line of treatment, which is significant for this patient population, where we don't have many options." 9 Patients taking Yervoy reported side effects: Diarrhea, fatigue, skin and inflammation of the intestines. 6 A risk evaluation and mitigation strategy (REMS) referred to by the Food and Drug Administration, established by Bristol-Myers help physicians manage and avoid adverse reactions, when Yervoy is administered to patients. 10

Madarex course of treatment for melanoma according to Bristol-Myers, consists of four injects (Ipilimumab) during a three month period, cost of $120,000. 9 In March 2011, the Food and Drug Administration approved Madarex for the treatment of advanced melanoma or metastatic melanoma. 1 The drug works different from chemotherapy, not using chemicals to attack the disease. 8 Also, Madarex is not toxic compared to chemotherapy according to Dr. Jeffrey Sosman, a professor at the Vanderbilt-Ingram Cancer Center in Nashville, Tennessee ("who took part in the clinical trial."). Future clinical trials will determine if Yervoy effectively treat many types of cancers, since the drug is not specific to eliminate any type of tumor. 9

The outlook for treating metastatic melanoma looks to save and extend patients lives by providing more treatment options. Roche and Plexxikon (drug companies) evaluating favorable clinical trials, drug to treat metastatic melanoma disease. 11

References:

1.) FDA Approves New Drug for Advanced Melanoma - http://www.newswise.com/articles/view/574893/?sc=rsmn

2.) Melanocytes - http://www.vitiligoguide.com/melanocytes/

3.) Melanoma - http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001853/

4.) Metastatic Melanoma - http://www2.mdanderson.org/depts/oncolog/articles/11/1-jan/1-11-compass.html

5.) Melanoma - http://www.patient.co.uk/health/Cancer-of-the-Skin-Melanoma.htm

6.) FDA approves melanoma drug shown to extend survival in patients - http://www.suntimes.com/news/metro/4511066-417/fda-approves-drug-that-extends-survival-for-melanoma-patients.html

7), Ipilimumab - http://en.wikipedia.org/wiki/Ipilimumab

8.) FDA clears first melanoma drug to extend survival - http://www.twincities.com/national/ci_17699774?source=rss&nclick_check=1

9.) CMC helped test landmark melanoma drug - http://www.charlotteobserver.com/2011/03/26/2171956/cmc-helped-test-landmark-melanoma.html#

10.) First Drug to Extend Survival in Late-Stage Skin Cancer - http://www.m.webmd.com/melanoma-skin-cancer/news/20110325/fda-approves-new-melanoma-treatment-yervoy?src=RSS_PUBLIC

11.) F.D.A. Approves Drug to Treat Melanoma - http://www.nytimes.com/2011/03/26/business/27drug.html

12.) Metastasis - http://en.wikipedia.org/wiki/Metastasis