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An immunotherapy treatment for melanoma patients that was clinically tested in Louisville is the first of its kind to gain approval from the U.S. Food and Drug Administration, according to a news release from the treatment's owner, Amgen Inc.
The therapy, called IMLYGIC, was tested at the University of Louisville's J. Graham Brown Cancer Center and in other U.S. sites. It was approved by the FDA Oct. 27 for the local treatment of patients with recurrent melanoma after initial surgery.
Amgen (NASDAQ: AMGN) wants to make the treatment available to patients in the United States within a week, according to the release.
IMLYGIC is a "big deal," said Brown Cancer Center deputy director Dr. Jason Chesney, because it's "the first time that a virus has been approved for the treatment of cancer."
Louisville Business First reported on Chesney's immunotherapy work as part of its "Cutting Edge Cancer Care" package earlier this month.
The Amgen therapy involves injecting a melanoma tumor with an “oncolytic virus” — in this case, a version of the herpes virus that has been engineered to activate the body’s immune system to attack cancer cells while not causing the patient to contract the virus.
The IMLYGIC oncolytic virus "causes the tumor to rupture and die," releasing antigens that may help trigger the body's immune system to fight future tumors, according to the Amgen news release.
The virus treatment was tested in Louisville and other locations as part of a study by Amgen, a California-based biotechnology company that owns a distribution facility in Louisville at 12000 Plantside Drive. The study enrolled 436 patients as part of the company's application for FDA approval, said Amgen director of corporate affairs Kelley Davenport.
Chesney said he has seen patients respond to IMLYGIC whose cancer still progressed when treated with other, already FDA-approved drugs.
That's why he thinks the new approval "means that lives will be saved," he said. And the treatment could be used for other cancer types. Another study is being planned for metastases from breast, lung, kidney, colon and other cancers.