After recording 89 percent of leukemia patients going into complete remission during initial trials, the U.S. Food and Drug Administration (FDA) put an experimental immunotherapy agent on the express train to market approval.

The CTL019, University of Pennsylvania's brain child, is personalized immunotherapy agent designated by US drug regulators as a "breakthrough therapy," meaning it will be reviewed faster and will get more attention from the FDA so it could be developed to be ready for the market.

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The FDA designates "breakthrough therapies" to new drugs for life-threatening conditions that are able to provide substantial improvement over an available therapy on at least one major clinical endpoint.

Being the very first cancer immunotherapy to receive a breakthrough designation, it is intended to cure relapsed or refractory acute lymphoblastic leukemia (ALL), a form of cancer that lead to abnormal white blood cells.

Last year, 89 percent of the 27 patients, including 22 children and five adults, have complete response to the cancer whereas their cancer has literally disappeared.

During the treatment, T-cells are extracted from ALL patients, which are genetically reprogrammed in the laboratory to target cancer cells that produce a protein called CD19. Patients are then injected with the new "hunter" cells where they multiply and attack cancer, getting rid of the disease.

Pennsylvania research team leader Carl June stated that the test results "reveal tremendous promise" especially to the desperate group of patients, since many were able to return to their normal lives after receiving the treatment.

With that, trials using CTL019 have begun in 2010 for patients with relapsed and refractory lymphocytic leukemia, non-Hodgkin lymphoma and myeloma. More researches are underway into Novartis AG's CAR therapies for ovarian, breast, mesothelioma and pancreatic cancers.

TagsLeukemia, Cancer, FDA, breakthrough, Acute Lymphoblastic Leukemia