A New FDA-Approved Therapy That Treats Leukemia and Lymphoma

Chimeric antigen receptor T-cell therapy, or CAR-T, is a precision medicine approach to treating certain forms of leukemia and lymphoma. The patients own cells are filtered and separated, then mixed with a deactivated virus that causes the cells to grow an artificial receptor that will track down the CD19 antigen expressed by these cancers. The modified T-cells are then reintroduced to the patient’s blood stream to begin therapy. Click here to read the press announcement from the FDA Newsroom.

The FDA’s August 2017 approval of the CAR-T therapy known as tisagenlecleucel for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia was the first gene therapy approved in the United States. Less than two months later, the approval of axicabtagene ciloleucel expands the milestone further and reinforces the FDA’s willingness to support these novel therapies.

Earlier this year, the FDA was in works to approve therapy which genetically alter’s a patient’s T-cells:

The FDA may soon approve a new cancer therapy that genetically alters a patient’s own existing T-cells to fight leukemia. This new, investigational treatment is known as CTL019 and is a type of chimeric antigen receptor T-cell (CAR-T) therapy.

CTL019 utilizes a process in which T-cells are carefully harvested from each individual leukemia patient. These patient-specific T-cells are then genetically reprogrammed to express a chimeric CD19 antigen receptor and subsequently transfused back into the specific patient from whom they were originally collected. Once back inside the patient, these reprogrammed T-cells multiply, hunt down, and attack CD19-positive leukemia cells.

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