(RNN) - The Food and Drug Association has approved the first cell-based gene therapy in the United States, opening the door for therapy that will attack and destroy cancer cells.
But advocacy groups are afraid the historic new drug may turn out to be the most expensive ever sold in the U.S.
The FDA-approved drug Kymriah has been called a “living drug” because involves using genetically modified immune cells from patients to attack their cancer, according to NPR.
The drug has been approved to treat children and young adults with lymphoblastic leukemia, a disease of the blood and bone marrow that is the most common childhood cancer in the U.S.
"New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses," said FDA Commissioner Scott Gottlieb.
The treatment involves altering the patient’s own immune system by removing T-cells and genetically modifying them to recognize, attack and kill cancer cells.
The drug has shown promising remission and survival rates in clinical trials, the FDA said.
While the drug marks a watershed moment in the treatment of cancer, it will cost about $450,000 for a round of treatment. The price is well below the $700,000 that was estimated before the approval of the drug.
Novartis, the company that makes the drug, chose the $450,000 price tag because it makes the medicine accessible while still returning a profit.
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