FDA Approves Personalized Gene Therapy as New Cancer Treatment

The Food & Drug Administration (FDA) approved a personalized gene therapy called CAR-T on Aug. 30, 2017 to treat children and young adults with B-cell acute lymphoblastic leukemia. With the approval of Kymriah, a genetically modified T-cell immunotherapy, cancer patients up to the age of 25 will gain access to this treatment.

B-cell acute lymphoblastic leukemia is a cancer of the bone marrow that spreads rapidly to several other parts of the body, such as the liver, lymph nodes, spleen and central nervous system. In other words, cancers may begin to form in these areas of the body. Chemotherapy is usually the main source of treatment for this type of cancer.

Administered doses of Kymriah are personalized according to one’s individual T-cells, which are white blood cells that help protect the body from viruses. In order to customize the treatment, the patient’s T-cells are sent to a manufacturing center where they are genetically modified to include a protein that orders T-cells to target leukemia cells. The genetically modified cells are then injected into the patient to start the treatment.

This approval by the FDA is a revolutionary step towards cancer research, as gene therapy continues to be a controversial topic between cancer researchers and government officials, with researchers advocating for more funding to cancer research. Despite its controversy and complexity, this treatment could save an average of 3,500 American lives each year.

On the dark side, concerns regarding price are beginning to pester consumers. Kymriah comes with a price tag of 475 dollars. Experts currently do not have a plan to make it more accessible and affordable since the drug has only recently been approved.