A new cancer treatment was approved unanimously by a Food and Drug Administration Panel on Wednesday, recommending for approval the first ever treatment that genetically alters patient’s cells to fight cancer. According to scientists, the treatment turns cells into “a living drug” to help the immune system fight cancer.
If the FDA moves forward with approval, the treatment will be the first gene therapy available on the market, a milestone which researchers and pharmaceutical giants have been striving to reach for decades. Approval of this treatment would make Switzerland-based Novartis the first pharmaceutical company to reach this goal.
The treatment would combat just one type of leukemia, and the company is working on similar treatments for other forms of leukemia, as well as for multiple myeloma and aggressive brain tumors. The approach requires a separate treatment to be created for each patient, with cells removed at a medical center, and then frozen and shipped to a Novartis plant for processing before they are shipped back to the treatment center.
Just one dose of this treatment has already allowed long-term remission and possibly even cures, for many patients in drug trials. These patients were out of options after every other available treatment had failed.
The FDA panel recommended approval of the treatment for B-cell acute lymphoblastic leukemia that has resisted other treatments or has relapsed, in patients between the ages of 12 and 25.
Tom Whitehead, the father of the first child to ever receive the treatment, said to the panel:
“We believe that when this treatment is approved it will save thousands of children’s lives around the world. I hope that someday all of you on the advisory committee can tell your families for generations that you were part of the process that ended the use of toxic treatments like chemotherapy and radiation as standard treatment, and turned blood cancers into a treatable disease that even after relapse most people survive.”
The company’s main evidence presented to panel was from a study which concluded in August of 2016. Of 63 patients in the study, 82.5 percent went into remission, an impressive figure for such a disease.