The U.S. Food and Drug Administration approved on Tuesday, Oct. 27, Amgen's drug Imlygic for treatment of melanoma abrasions in lymph nodes and skin. The first of its kind, Imlygic makes use of genetically engineered live oncolytic herpes virus to bust up melanoma tumors that cannot be removed through surgery.
The therapy includes injecting Imlygic directly onto the melanoma abrasions where the virus reproduces inside cancer cells and eventually cause the cells to bust open and die. The Imlygic therapy consists of multiple administrations where the second dose is given three weeks following the initial dose. Additional doses are given every two weeks for a minimum of six months. Patients have the option to continue the therapy until another kind of treatment is advised or until there are no more lesions that can be treated using the Imlygic therapy.
"Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat. This approval provides patients and health care providers with a novel treatment for melanoma," said Dr. Karen Midthun, FDA's Center for Biologics Evaluation and Research director.
The National Cancer Institute estimated 74,000 patients in America will be diagnosed with the disease wherein approximately 10,000 patients will die because of it in 2015. Melanoma, often caused by UV light exposure, is the deadliest type of skin cancer and most common in the U.S.
In a clinical study that involved 436 patients with metastatic melanoma, 16.3 percent of the participants who received Imlygic showed a decrease in the size of the lymph nodes and skin lesions. Only 2.1 percent of the patients who received a comparator therapy saw this improvement. While the drug therapy did not affect the overall survival of patients, extend life-span or improve symptoms of patients whose cancer has spread to critical organs, Imlygic therapy provides reprieve from the melanoma.
In a press release, Dr. Howard L. Kaufman, principal investigator for the pivotal trial (OPTiM), expressed that treatment of advanced melanoma, given its complexity, still requires numerous modalities.
"As an oncolytic viral therapy, Imlygic has a unique approach, and provides another option for treating eligible patients with unresectable disease that has recurred after initial surgery," added Kaufman who is also the Society for Immunotherapy of Cancer president and the associate director of the Clinical Science at the Rutgers Cancer Institute of New Jersey.
The FDA notes several side effects of the drug such as pain in the injected area, flu-like symptoms, fever, nausea, chills and fatigue. Since Imlygic involves genetically modified herpes virus, it should not be administered to pregnant women or in patients with weak immune system.
Photo: Nicola Sapiens De Mitri | Flickr
