Navigation Links
FDA approves new drug for advanced melanoma

BOSTON--The U.S. Food and Drug Administration today approved the use of ipilimumab for the treatment of previously treated metastatic melanoma. It is the first drug approved for metastatic, or advanced, melanoma is more than a decade.

"Ipilimumab is the first in a new class of drugs that has been shown to offer a survival benefit for metastatic melanoma, which is often a fatal disease, and hopefully, this will lead to the development of related treatments for other cancers," said F. Stephen Hodi, MD, director of the melanoma treatment center at Dana-Farber Cancer Institute and a lead investigator of the national clinical study of ipilimumab.

The number of cases of metastatic melanoma, considered to be one the most serious form of skin cancer, has increased during the past 30 years, and its death rate is rising faster than most other cancers. The American Cancer Society estimated that the disease was diagnosed in more than 68,000 Americans and be responsible for 8,700 deaths in this country in 2010.

Ipilimumab, developed by Bristol-Myers Squibb and Medarex, is a monoclonal antibody that consists of millions of copies of a human antibody that binds to CTLA-4 protein molecule on T cells white blood cells that patrol the body for signs of illness. CTLA-4 serves as a control switch for the immune system's response to disease. With no antibody attached, CTLA-4 suppresses the immune response. Ipilimumab reverses that condition, unleashing the immune attack on abnormal cells, including cancer cells.

Last year, Hodi reported at the annual meeting of the American Society of Clinical Oncology and in the New England Journal of Medicine findings from a phase III trial involving 676 patients with advanced (stage III or IV), inoperable melanoma that had worsened during prior therapy for metastatic disease.

Patients were randomly assigned to receive one of three treatment regimens: ipilimumab and the gp100 vaccine (which seeks to spark an immune response by presenting the immune system with a protein fragment associated with cancer); ipilimumab alone; or gp 100 alone.

The median survival period for patients receiving ipilimumab plus gp100 was 10 months, compared with 6.4 months for those receiving gp100 alone. The median survival for participants receiving ipilimumab alone was 10.1 months.

In the ipilimumab-alone group, nine of 15 patients continued to benefit from the therapy for at least two years, as did four of 23 patients in the combination therapy group.

About 60 percent of the patients treated with ipilimumab experienced adverse side effects to the therapy, as did 32 percent of the patients treated with gp100. The complications were generally immune system-related and most often affected the skin and gastrointestinal tract. The most common included diarrhea, nausea, constipation, fatigue, decreased appetite, and rash. While the adverse effects could be severe and long-lasting, most of them were reversible with appropriate treatment.

"While ipilimumab, on average, extended the lives of patients by four months, there is also a group of patients who experienced a greater benefit and lived many months while being treated with this drug," said Hodi. "This is a big step in the right direction because it demonstrates that this class of drugs can benefit cancer patients."


Contact: Bill Schaller
Dana-Farber Cancer Institute

Related medicine news :

1. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
2. The American Association of Anatomists approves guidelines for body donation programs
3. Golden Meditech Shareholders Approves of Name Change
4. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
5. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
6. House of Representatives Approves Health-Care Reform Bill
7. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
8. FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
9. FDA approves first human neural stem cell clinical trial to treat brain tumors
10. Early detection of cancer: The FDA approves procedure discovered by EPFL researchers
11. FDA approves Merz Pharmaceuticals Xeomin (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm
Post Your Comments:
Related Image:
FDA approves new drug for advanced melanoma
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Charitable giving ... charitable donations are made in the last five weeks of the year totalling over ... created in 2012 to connect the nation’s charities with those individuals who want to ...
(Date:11/24/2015)... (PRWEB) , ... November 25, 2015 , ... ... technologies and development solutions for drugs, biologics, consumer health and global clinical supply ... present at the upcoming Clinical Trial Supply East Asia Conference, to be held ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Preparing for ... p.m. – 3:00 p.m. EST, , FDA has long asserted that ... regulations apply to performing the tests and do not meet the device regulations. , ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... ... LENR HHT Bolier Reactor System. Brillouin is the developer of renewable energy technologies ... low energy nuclear reactions (“LENR”), announced today that its WET™ and HHT™ Boiler ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... , Nueva York , ... Biomedical Devices (ABD), fabricante del Avery Breathing Pacemaker ... Anders Jonzon , MD; Ph.D. como consultor clínico. ...   --> Foto - ... --> El doctor Jonzon es un fisiólogo ...
(Date:11/24/2015)... 24, 2015 --> ... Biologics Market by Product Type (Bone Graft, Bine Graft Substitute, ... Fusion, Posterior Lumbar Interbody Fusion), End User, and Geography - ... was valued at $1.90 Billion in 2014 and is expected ... 4.4% during the forecast period of 2015 to 2020. ...
(Date:11/24/2015)... FRAMINGHAM, Mass. , Nov. 24, 2015   ... leading innovator of less-invasive, miniaturized circulatory support technologies that ... announced that President and Chief Executive Officer Doug ... Jaffray 27 th Annual Healthcare Conference on December ... being held December 1-2 in New York ...
Breaking Medicine Technology: