The company says the treatment will cost an average of $65,000.
An approach deemed novel by the Center for Biologics and Drug Evaluation at the FDA, Imlygic (talimogene laherparepvec ot T-Vec)—an oncolytic virus therapy—was granted approval by the FDA close on the heels of the support in Europe.
Imlygic, a genetically modified live oncolytic herpes virus therapy, is used to treat unresectable melanoma lesions. Designed to be injected directly into the melanoma lesions, the virus replicates inside cancer cells and causes the cells to rupture and die. The treatment, says the FDA release, consists of a series of injections—the first 2 separated by 3 weeks and the consequent injections are intended to be administered every 2 weeks for at least 6 months, unless the patient requires other treatment or all lesions have been treated.
Manufactured by the Amgen subsidiary BioVex Inc, the NDA for Imlygic included results from a multicenter study with 436 enrollees who had unresectable metastatic melanoma. Following a minimum of 6 month treatment, the study found that about 16% of participants treated with the virus had a reduction in lesion size, both on the skin and in lymph nodes, which lasted a minimum of 6 months. Only about 2% of participants on the comparator therapy showed a reduction in lesion size.
“Imlygic is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer. It provides an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. Harper informed on ongoing follow-up studies that are evaluating whether combining the virus with immunotherapies can have a bigger impact on outcomes.
Howard Kaufman, MD, agrees with Harper. Kaufman, associate director of Clinical Science at the Rutgers Cancer Institute of New Jersey, led the pivotal OPTiM trial for the treatment. “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, Kaufman said.
The question now is the cost of the therapy. Expected to be available within a week, the company says the treatment will cost an average of $65,000. Anticipating dosing variability, Amgen has promised to work with eligible participating institutions to limit the average treatment cost of Imlygic to $65,000. The company has developed the following assistance programs in the United States: