The Oncologic Drugs Advisory Committee has unanimously endorsed first-of-its-kind cancer treatment that uses patients’ revved-up immune cells to fight the disease.
The advisory commitee has decided that the therapy’s benefits for desperately ill children far outweigh its potentially dangerous side effects.
This means that the Novartis treatment could be approved by the FDA by the end of September and becoming so the first gene therapy approved in the United States
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.”
“This will be a historic approval,” said Brad Loncar, chief executive of Loncar Investments which runs the Loncar Cancer Immunotherapy ETF. “As an investor I’ve never seen anything like it. It’s an entirely new way of treating cancer.”
The panel was asked to focus on the safety concern as it was already well established the efficacy.
As explained in the company’s press release: “CAR-T is different from typical small molecule or biologic therapies because it is manufactured for each individual patient using their own cells. During the treatment process, T-cells are drawn from a patient’s blood and reprogrammed in the manufacturing facility to create T cells that are genetically coded to express a chimeric antigen receptor to recognize and fight cancer cells and other B-cells expressing a specific antigen.”
The turnaround time for manufacturing the therapy, called “vein-to-vein” time, will be an estimated 22 days, Novartis officials told the committee Wednesday.
TThe FDA is not obliged to follow the recommendations of its advisers but typically does so.
Another important aspect for the CAR-T cell therapy is the cost hasn’t been discussed because that is beyond the FDA’s purview. Novartis hasn’t released pricing information.