It's not everyday the future of cancer care changes forever. In April of this year, we first discussed the emergence of a modified version of the herpes virus anticipated to make waves in therapeutic care for patients with advanced melanoma. Now the drug, slated to be the first-ever virus approved for the treatment of cancer, has been recommended by the European Medicines Agency (EMA); a rubber stamp for approval for the European Commission.
Imlygic (the trade name of the virus) will be used in the treatment of adults with inoperable melanoma that is regionally or distantly metastatic with no bone, brain, lung or other visceral disease.
For many, metastatic melanoma represents an impending and inevitable death sentence. In 2012 there was an estimated 55,500 deaths from malignant melanoma worldwide. Not only is it difficult to treat, but it also requires a multi-modal approach in the majority of cases.
Imlygic, which is injected directly into the tumor, is derived from the herpes simplex virus (HSV-1), more commonly known for causing unsightly cold sores. The virus has a two-fold approach: 1) it will specifically enter and destroy tumor cells and 2) will elicit an immune response that will recruit the immune system to attack the tumor.
The virus has been shown to reduce tumor size but has yet to show a statistically significant improvement in survival. In it's most recent clinical trial, Imygic was four times better than standard care.
The drug's owners, Amgen, have also begun to partner with other pharmaceutical companies like Merck and Roche in collaborative studies. The researchers aim at investigating the safety and efficacy of drug combination therapy with Imlygic on a host of cancers, inclusive of melanoma, squamous cell cancer of the head and neck, triple negative breast cancer and colorectal cancer with liver metastases.
With the drug all but approved in Europe, attention now turns to the FDA, which is scheduled to give its evaluation of the drug by October 27th. Regardless of how the U.S. agency rules, Imygic is the start of the future for cancer treatments. Modified viruses, gene therapy and CRISPR-Cas9 will, in the coming years, revolutionize cancer treatment.