The injection, called talimogene laherparepvec, is a so-called oncolytic immunotherapy, using a genetically modified strain of the herpes virus to invade tumors and replicate itself, thereby killing cancer and spurring an immune response to multiply its effect.
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It is meant for patients with hard-to-treat melanoma, the deadliest form of skin cancer.
Imlygic is engineered through the genetic adjustment of the herpes simplex 1 virus to secrete the cytokine GM-CSF within the tumor, causing cell lysis. The primary endpoint was durable response rate (DRR, objective response for at least 6 months).
“However, Imlygic has not been shown to improve overall survival or to have an effect on melanoma that has spread to the brain, bone, liver, lungs, or other internal organs”, the FDA noted. Amgen said patients should be treated with the drug for at least six months, with estimates that one course of treatment will cost about $US65,000 ($A90,334). Imlygic was administered initially at less than or equal to 4 mL x10 PFU/mL for three weeks followed by less than or equal to 4 mL x10PFU/mL every two weeks. The drug divides into copies repeatedly until the membranes, or outer layers, of the cancer cells burst.
The CHMP’s recommendation draws from the findings of a global, randomized, open-label 436-patient Phase 3 clinical trial that evaluated the efficacy and safety profile of the intralesional injectable in patients with unresectable Stage IIIB, IIIC or IV melanoma, compared to treatment with a granulocyte-macrophage colony-stimulating factor (GM-CSF).
Cancer patient Hilde Stapleton, left, waits with her husband George during an examination at The University of Texas MD Anderson Cancer Center Wednesday, May 27, 2009 in Houston. Visible tumors were injected with the drug.
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“[Imlygic] represents a new approach to treating melanoma, a cancer that is increasing in incidence at an alarming rate”, Tim Turnham, executive director, Melanoma Research Foundation, said in a statement. Imlygic is manufactured by BioVex Inc., a subsidiary of Amgen Inc.
