June 2018

FDA Approves the First Cell-based Gene Therapies in the United States

The U.S. Food and Drug Administration (FDA) approved the first new cell-based gene therapies known as “CAR-T.” Kymriah and Yescarta were both approved to treat different forms of cancer.

Kymriah, manufactured by Novartis, was approved for the treatment of patients up to 25 years of age with acute lymphoblastic leukemia (ALL) who are not responding to treatment or in second or later relapse.1 Yescarta, manufactured by Kite, a Gilead Company, was approved to treat adult patients with diffuse large B-cell lymphoma (DLBCL) who have not responded to or who have relapsed after at least two other kinds of treatment.2

Kymriah and Yescarta are covered under standard medical benefit plans and are subject to a medical necessity review. Cigna performs medical necessity reviews for both Kymriah and Yescarta through a dedicated team that consists of specialized transplant case managers and medical directors who have knowledge in handling genetic therapies. Customers authorized to receive these therapies are assigned to a case manager who will coordinate care.

For more information about Kymriah and Yescarta, click here.

  1. FDA approval brings first gene therapy to the United States. FDA News Release. August 30, 2017. Retrieved from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm
  2. FDA News Release: FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma. October 18, 2017. Retrieved from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm581216.htm