
Cost Questions Will Follow the Approval of Amgen's Oncolytic Viral Treatment, Imlygic
The company says the treatment will cost an average of $65,000.
An approach
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
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,”
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,
The question now is the cost of the therapy. Expected to be available within a week, the
- Free medicines through The Safety Net Foundation for qualifying individuals
- Co-pay coupon program through the Amgen FIRST STEP Program for commercially insured patients
- Information about independent co-pay assistance foundations that give grants to qualifying patients.
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