A new immunotherapy, (CAR-T) treatment has been developed for advanced leukaemia in children and young adults where prior standard treatment has failed. Dr. Tim Cripe, a specialist oncologist at Nationwide Children’s Hospital in Ohio, described the experimental therapy CTL019 produced by Swiss pharma company Novartis as “the most exciting thing I’ve seen in my lifetime.” It will go before the American FDA (Food and Drug Administration), for approval on 3 October.
This is the first customised immunotherapy treatment to come before the U.S. Food and Drug Administration,(FDA) for approval. The process harvests a patient’s white blood cells for modification before infusing them back into the patient’s body where they can hunt, recognise and kill the targeted cancer cells.
A further FDA decision will be made on 29 November for KTE-C19, another CAR-T therapy treatment produced by California based Kite Pharma, for advanced and aggressive Non-Hodgkin’s Lymphoma in adults.
These companies, together with the Seattle based biopharmaceutical company Juno Therapeutics and others, can be expected to progress with a number of such immunotherapies that hotwire white blood cells to treat for tumours in lung, pancreatic, gastric and breast cancer patients.
There are a number of pharmaceutical companies and clinical researchers have been working to advance this exciting immunotherapeutic technology of adoptive cell transfer for five years or more. Dr. Renier Brentjens of the Memorial Sloan Kettering Cancer Center in New York, a trial leader in this technology, stated recently that the on-going trials “are proof of principle that we can successfully alter patients’ T cells so that they attack their cancer cells”.
Harnessing a patient’s immune system to combat disease rather than treating by standard surgery, radiation and chemotherapy, could transform cancer treatment for a growing number of patients over the next decade.
National Cancer Institute
Car T-Cell Therapy: Engineering Patients’ Immune Cells to Treat Their Cancers.
Dana-Farber Cancer Institute
Cellular Therapies Programme
FDA U.S. Food and Drug Administration
Drug and Device Development Processes and Approvals
[Illus credit: Dana-Faber Cancer Institute