Timothy Cripe, a panel member who is an oncologist with Nationwide Children's Hospital in Columbus, Ohio, called the treatment the "most exciting thing I've seen in my lifetime".
An FDA advisory committee voted unanimously in favor of the regulator approving Novartis' experimental CAR-T cell therapy, a move that signals the likely arrival of a dramatically new type of cancer treatment.
The approach is also being tested for a range of diseases from non-Hodgkin lymphoma and multiple myeloma to solid tumours.
If cleared by the FDA, it would be the first gene therapy approved in the United States.
"It is not uncommon for the companies who make these products to manage supply closely", said Elizabeth Kalina, a spokeswoman for Shire, which is building a new manufacturing facility that's slated to open in Georgia in 2018.
This super charges the T-cells to attack B-cells, which are immune cells that turn malignant in leukemia.
The product is made by extracting and isolating a patient's T cells, genetically engineering them to recognize and target cancer cells, and then infusing them back into the patient.
Once inside the body, the cells multiply exponentially and go hunting for the CD19 protein, which appears on a kind of white blood cell that can give rise to diseases, such as leukemia and lymphoma.
The treatment is the result of a joint effort between the University of Pennsylvania and pharmaceutical giant Novartis. The immune cells from the patient's blood are being reprogrammed to focus on cancer cells and completely destroy them without doing any damage to the healthy cells that are around it. The first of which is the safety risks discussed during the advisory panel committee.
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In Novartis' pivotal ELIANA study, just over three quarters of patients experienced CRS of some grade, while 44% developed neurotoxicity. But there were no cases of fatal brain swelling, as occurred in another company's trial, Grupp said. Therefore, only about 30 or 35 medical centers will have access to the treatment upon its release.
Millions T-cells (a type of immune cell) are from removed the patient's blood.
In a unanimous decision, members of FDA's Oncologic Drugs Advisory Committee agreed to recommend an innovative cancer therapy for regulatory approval.
David Maloney, medical director for cellular immunotherapy at Fred Hutchinson Cancer Research Center in Seattle, said he was elated that the field is moving forward.
Austin Schuetz, one of a handful of CAR-T patients to achieve multi-year remission of his cancer, requires biweekly infusions of immunoglobulin to replace B-cells wiped out by the engineered cancer-killing T-cells.
Assuming this treatment is approved, it will be a first for the FDA. Novartis hasn't released pricing information.
Arie Belldegrun, CEO of Novartis' rival Kite Pharma, which is developing a CAR-T therapy that was filed shortly after CTL019, said that during the meeting he would be "Novartis' biggest cheerleader". "Our children deserve this chance", she said.
For other parents, there were happier outcomes. He has since returned to playing hockey.
Belldegren said he had been "amused" by the "horse race metaphors" used to describe the companies' attempts to get their therapies to market. The severe side effects of raging fever, crashing blood pressure and lung congestion almost killed her, but she has remained cancer-free since then.