Thousand Oaks, CA - A new virus has been approved by the Federal Drug Administration (FDA) to treat cancer, especially in patients with stage three melanoma. The new treatment called Imlygic was developed by Amgen, a biotechnology company.
“Today’s approval extends its use to patients who are at high risk of developing recurrence of melanoma after surgery,” said the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, Dr. Richard Pazdur. “This new use of the drug in earlier stages of the disease builds on our understanding of the immune system’s interaction with cancer.”
It’s the first of its kind, being a live virus that’s infectious and also approved for use to treat cancer. It works by attacking cancer cells when the human virus-fighting machinery typically shuts down.
“Today’s approval marks the first new FDA-approved adjuvant option in 20 years,” said the executive director of the Melanoma Research Foundation, Dr. Tim Turnham. “This approval means stage three melanoma patients have a powerful new tool to help prevent their disease from progressing.”
“What this really is, in the end, is proof of concept,” said John Bell, a cancer researcher at the Ottawa Hospital Research Institute. Bell helped to create the treatment.
“It’s a totally new class of weapons that we can now use,” said Antonio Chiocca, a neurosurgeon at Brigham and Women’s Hospital. In fact, the virus is a manipulated version of the herpesvirus, which infects cancer cells and bursts them into tiny particles. “The immune system sees all the debris. This makes the immune system wake up and say, ‘Hey, there’s something going on here. Let’s check it out.”
Imlygic has taken the oncology world by storm because it has overcome the issues associated with injecting a live virus into the human body and helps the patient’s immune system join the fight versus the cancer cells.
Creating the virus was no easy feat. Trying to not cause cold sores and not infect healthy cells while developing a protein to boost the immune system was challenging. But now, a dozen or more clinical trials for even more anti-cancer viruses are underway.
Bell is researching with a virus related to smallpox and Duke scientists are using a poliovirus. Oncolytics Biotech is experimenting with a reovirus.
Howard Kaufman, an oncologist at Rutgers Cancer Institute of New Jersey, said the virus “suffers from an acute lack of understanding the science behind it.” For example, researchers wonder if the immune system kicks in and kills just the cancer cells or others as well, and if it can identify them regardless of where they’re located in the body.
Although Imlygic hasn’t proved amazing survival rates for patients, its side effects are super mild, and when used in combination with other treatments, it can be very effective. These other drugs are checkpoint inhibitors, which help to stimulate the immune system.