Click here to read the press announcement from the FDA Newsroom.

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.

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.