Release date: 2015-10-29
On October 27, local time, Amgen announced that the FDA has formally approved the application for biologics license for its IMLYGIC (talimogene laherparepvec, T-Vec). T-Vec is an oncolytic virus genetically engineered by herpes simplex virus type 1 for topical treatment of melanoma patients who have relapsed after the first surgery. T-Vec is the first oncolytic virus therapy approved by the FDA, with an estimated average cost of treatment of approximately $65,000.
In fact, this is the second good news about the T-VEC that Amgen has recently harvested. On October 23, Anjin official website news, the European Medicines Quality Administration Human Drugs Committee (CHMP) recommended T-VEC for the treatment of malignant melanoma.
According to reports, T-Vec can replicate and release granulocyte-macrophage colony-stimulating factor (GM-CSF) in tumor cells after injection into tumor tissues. T-Vec can lyse or kill cells, release tumor-specific antigens, and promote anti-tumor immune response together with GM-CSF.
The main data for T-Vec comes from a phase 3 multicenter, unblinded, randomized clinical trial called OPTiM. OPTiM enrolled 436 patients, of whom 16.3% received T-Vec treatment with a sustained response (complete or partial response lasted at least 6 months), compared with 2.1% in the control GM-CSF treatment group. Of the patients who responded persistently, 29.1% achieved a complete response and 70.8% achieved a partial response.
T-VEC was originally developed by BioVex, and Amgen acquired BioVex in 2011 for $425 million in cash. On April 30th, the US FDA's CTGTAC and ODAC experts supported T-Vec for advanced melanoma treatment with a 22:1 absolute advantage; therefore, the T-VEC approval by the FDA is not a surprise. Amgen plans to launch the product within a week under the trade name Imlygic.
Dr. Sean E. Harper, Executive Vice President of Research and Development, Amgen said: "IMLYGIC is the first clinically and regulatory approved oncolytic virus therapy; however, not all melanoma patients can benefit from this therapy. Currently, we are studying IMLYGIC Combination with other immunotherapies (Keytruda in Merck, atezolizumab from Roche, etc.) for the treatment of advanced melanoma and other solid tumors."
Source: Bio-Exploration
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