FDA approves first-in-class Amgen melanoma drug
pharmafile | October 28, 2015 | News story | Research and Development, Sales and Marketing | Amgen, Imlygic, melonoma
The US Food and Drug Administration (FDA) has approved Amgen’s Imlygic for the treatment of melanoma lesions in the skin and lymph nodes, making the treatment the first FDA-approved oncolytic virus therapy.
Imlygic (talimogene laherparepvec), manufactured by Amgen subsidiary BioVex, is a genetically modified live oncolytic herpes virus therapy used to treat melanoma lesions that cannot be completely removed by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes them to rupture and die.
This process is particularly effective, as it causes the destroyed cancer cells to release new infectious virus particles that help destroy other surrounding cancer cells.
An Imlygic treatment course consists of a series of injections into the melanoma lesions. The initial injection is followed by a second dose three weeks later, which is in turn followed by additional doses every two weeks for at least six months, unless other treatment is required or until there are no remaining injectable lesions to treat.
Skin cancer is the most common form of cancer in the US. The melanoma form of skin cancer is the leading cause of skin cancer related deaths, and is most often caused by exposure to ultraviolet (UV) light. According to the National Cancer Institute, approximately 74,000 Americans will be diagnosed with melanoma and nearly 10,000 will die from the disease in 2015.
“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” says Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “This approval provides patients and health care providers with a novel treatment for melanoma.”
Sean Harper, executive vice president of Research and Development at Amgen, comments: “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. Not all melanoma patients currently benefit from available therapies, and IMLYGIC represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease.
“Immunotherapy is an exciting area for cancer research, and we are currently studying Imlygic in combination with other immunotherapies in advanced melanoma and other solid tumours.”
Imlygic’s safety and efficacy were evaluated in a 436-patient trial, where the participants’ melanoma lesions in the skin and lymph nodes were treated with Imlygic or a comparator therapy for at least six months, or until there were no remaining injectable lesions.
The study showed that 16.3 percent of the study participants who received Imlygic experienced a decrease in size of their skin and lymph node lesions, lasting for a minimum of six months, compared to 2.1 percent of the study participants receiving the comparator therapy.
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 most common side effects observed in clinical study participants were fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site, and because Imlygic is derived from the herpes virus, herpes virus infection can also occur.
Because of this, the Administration recommended that Imlygic should not be given to individuals with suppressed immune systems or who are pregnant.
Amgen said it intends to make Imlygic available to US patients within a week, and that the average cost would be approximately $65,000.
Imlygic was approved in Europe last week for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic with no bone, brain, lung or other visceral disease.
Joel Levy
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