The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.
“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “This approval provides patients and health care providers with a novel treatment for melanoma.”
Skin cancer is the most common form of cancer in the United States. Melanoma, one type of skin cancer, is the leading cause of skin cancer related deaths, and is most often caused by exposure to ultraviolet (UV) light. According to the National Cancer Institute approximately 74,000 Americans will be diagnosed with melanoma and nearly 10,000 will die from the disease in 2015.
Imlygic, a genetically modified live oncolytic herpes virus therapy, is used to treat melanoma lesions that cannot be removed completely by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die.
The US Food and Drug Administration has approved SonaCare Medical’s Sonablate 450 focused ultrasound system for the ablation of prostate tissue. Focused ultrasound enables treatment of organ-confined prostate disease while preserving surrounding healthy tissue, without radiation or surgery.
“For men with conditions like prostate cancer, the option of a non-invasive procedure that can selectively target and treat diseased tissue is very appealing,” says Neal Kassell, MD, Chairman of the Focused Ultrasound Foundation. “American men have been traveling overseas for focused ultrasound treatment for prostate diseases for years, and we are pleased that they will now have access to this innovative treatment at leading centers in the United States.”
A University of Kentucky study shows that withaferin A, a component of Withania somnifera (winter cherry) plant extract, may hold promise as a new treatment for non-Hodgkin’s lymphoma.
Winter cherry extract was used in traditional Ayurvedic Indian medicine for thousands of years before it caught the interest of Subbarao Bondada, a University of Kentucky College of Medicine professor and researcher for the UK Markey Cancer Center. Because withaferin A shows promise in treating other cancers without the side effects associated with current treatments, Bondada’s laboratory tested it against lymphoma. Non-Hodgkin’s lymphoma is one of the most common cancers in the U.S. and is known for being particularly aggressive.
An investigational medical device for the treatment of late stage lung cancer, pioneered by researchers at University of Kentucky, has been approved for clinical trials by the Food and Drug Administration (FDA). UK is the only site in the country approved to test this new treatment on advanced lung cancer patients.
The Exatherm Total Body Hyperthermia System (Exatherm-TBH) was developed at UK in a public-private partnership with Exatherm Inc. The project is supported by grant funding from the National Institutes of Health.
The research team includes Dr. Jeremiah Martin, surgical director of the UK Markey Cancer Center’s Multidisciplinary Lung Cancer Clinic; and Dr. Kevin Hatton, chief of anesthesiology critical care at UK.