March 25, 2011 — The US Food and Drug Administration (FDA) announced today the approval of ipilimumab (Yervoy, Bristol-Myers Squibb) for the treatment of advanced melanoma as a second-line therapy.
"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. Ipilimumab "is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."
Ipilimumab is another targeted therapy for cancer, but represents a new class of drug, known as a targeted T cell antibody, Ipilimumab is directed against an antigen on the surface of T cells. The antigen, cytotoxic T lymphocyte–associated antigen 4 (CTLA-4), acts as a brake on the T cell, By blocking the brake, the T cell goes into attack mode and kills cancer cells.
The FDA noted in its approval announcement that the common adverse effects that can result from autoimmune reactions associated with ipilimumab 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% of patients treated with ipilimumab. When severe adverse effects occurred, the drug was stopped and corticosteroid treatment was started
source:medscape
"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. Ipilimumab "is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."
Ipilimumab is another targeted therapy for cancer, but represents a new class of drug, known as a targeted T cell antibody, Ipilimumab is directed against an antigen on the surface of T cells. The antigen, cytotoxic T lymphocyte–associated antigen 4 (CTLA-4), acts as a brake on the T cell, By blocking the brake, the T cell goes into attack mode and kills cancer cells.
The FDA noted in its approval announcement that the common adverse effects that can result from autoimmune reactions associated with ipilimumab 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% of patients treated with ipilimumab. When severe adverse effects occurred, the drug was stopped and corticosteroid treatment was started
source:medscape
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