A U.S. Food and Drug Administration (FDA) advisory committee gave a unanimous recommendation for the approval of a “living drug” treatment. This is a new approach in the fight against a common form of leukemia.
The FDA does not necessarily have to follow its advisory committee recommendation, but in most cases, it does. As such, most see this as a significant milestone in getting this new therapy approved.
The Living Drug is Based on Personalized Cancer Treatment Methods
This new type of cancer treatment is based on genetically engineered cells. These are collected from the patient, reprogrammed, and then reinfused in the body. Then, they should determine the immune system to attack and fight against the disease.
If approved, this living drug could the first FDA recognizes and authorizes a treatment considered “a gene therapy product”.
In recent years, researchers trying to find new cancer treatments shifted their attention to a new area. One which makes use of the body’s own immune system and its abilities, namely, “immunotherapy”. Some consider this one of the most important developments in decades, this ability to make the body naturally fight back by itself.
There are still some concerns regarding these new potential treatments. Although they generated much hope, they also raised concerns as to their safety on the long term. They also come with questions regarding the costs of such therapy.
Nonetheless, the FDA’s advisory committee returned a 10-0 vote recommending the approval of the living drug against leukemia. This could come to be used by either children or young adults.
“This is a major advance and is ushering in a new era in treating children,” stated Dr. Malcom Smith, a National Cancer Institute associate branch chief for pediatric oncology.
“This is the most exciting thing I’ve seen in my lifetime,” declared Dr. Timothy Cripe, who is an oncologist at the Columbus, Ohio Nationwide Children’s Hospital.
This recommended living drug treatment is known as the CAR-T cell immunotherapy. The drug endorsed by the committee is tisagenlecleucel or CTL019. It was developed to treat patients aged 3 to 25 years old that relapsed after following the standard treatment used in B-cell acute lymphoblastic leukemia. This is the most common type of childhood cancer in the U.S.
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