The Food and Drug Administration approved Wednesday a new drug therapy for pediatric leukemia that uses immunotherapy, or the re-engineering of a person’s own T cells to enable them to fight cancer.
“The Food and Drug Administration has just approved for the first time a living therapy and immunotherapy that we can use to treat cancer. That is unprecedented, it’s never happened before,” said Dr. Damian Green, a clinical researcher at Fred Hutchinson Cancer Research Center.
Both Fred Hutchinson Cancer Research Center and the Ben Towne Center for Childhood Cancer Research have been conducting trials to prove the efficacy of using immunotherapy as a tool in treating childhood leukemia.
The FDA approval involves the drug Kymriah, which was developed by the Swedish pharmaceutical company Novartis.
Kymriah will include strict guidelines for use in children up to 25 years old with relapsed acute lymphoblastic leukemia.
Locally, studies involving a similar therapy have seen great success, and trials are ongoing.
“This therapy has been really so successful; 93 percent of children here on our trial with this therapy have gone into full remission. These are children who had previously been resistant to lots of different kinds of chemotherapy, so this is really an exciting result,” said Dr. Colleen Annesley, a pediatric oncologist at Seattle Children’s hospital.
Oncologists and researchers have been working years to this day and believe this turns the corner in the fight against cancer as well as treatment for other significant illness.
“The way for us to move this to other types of cancer is for us to continue to have support from the community, from the federal government through the funding that allows us to do this research that got us to this point and our partnerships with industry as well,” said Green.
The hope is that using immunotherapy to cure leukemia, the most common childhood cancer, will eventually be more successful than current therapies like chemotherapy and radiation, which often cause significant health problems for kids whose bodies are still developing.
The cost of this newly approved drug is $475,000, which is thought to be lower than expected. A big part of that cost is the unique way the drug is administered. T cells are harvested from each patient and then re-engineered to kill cancer cells, before being put back in the patient which then begins the treatment.
But, Novartis is supposedly working with Medicare-Medicaid on a unique plan where reimbursement would only be made if patients responded to treatment within one month.