Topline
The Food and Drug Administration approved a groundbreaking cellular treatment Friday for two types of advanced melanoma aimed at combating tumor growth in adult patients with the skin cancer who have already attempted other treatments, potentially transforming future treatment on advanced cancer tumors.
The FDA on Friday approved a groundbreaking treatment for advanced melanoma.
Key Facts
Amtagvi, a treatment developed by California-based Iovance Biotherapeutics, is intended to treat adult patients with metastatic melanoma who had previously tried and did not improve after taking other drugs, such as immunotherapy with a PD-1 blocking antibody.
The FDA’s approval clears the way for patients with melanoma that has either spread, becoming metastatic, or was unable to be removed through surgical intervention, referred to as unresectable melanoma.
Amtagvi acts by boosting the body’s immune cells inside skin cancer tumors among patients with either unresectable or metastatic melanoma, which Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, warned can be fatal.
The treatment was approved under the FDA’s accelerated approval pathway, a process in which it can fast-track drug approval for life-threatening illnesses, following clinical trials.
Amtagvi boasted a 31.5% response rate among 73 patients in trials, with three patients exhibiting a complete response and 20 others showing a partial response, with roughly half of those patients showing no signs of tumor progression after six, nine and 12 months from the time they took the drug.
Melanoma is often caused by skin exposure to ultraviolet light, the type of light invisible to the human eye that comes from the sun or indoor tanning beds.
Big Number
More than 77,200. That’s how many new cases of melanoma were reported in 2020, when just over 8,200 people died of the skin cancer, according to the Centers for Disease Control and Prevention. Melanoma represents roughly 1% of skin cancer cases in the U.S.
Further Reading
How Sunscreen Prevents Skin Cancer—Despite The Conspiracies Peddled By Social Media Influencers (Forbes)
Merkel Cell Carcinoma: What To Know About The Skin Cancer That Killed Jimmy Buffett (Forbes)
Barbara Terrio is a seasoned business journalist, delving into the world of finance, startups, and entrepreneurship. With a knack for demystifying complex economic trends, she helps readers navigate the business landscape. Outside of her reporting, Barbara is an advocate for financial literacy and enjoys mentoring aspiring entrepreneurs.
