On Aug. 30, 2017, the U.S. Food and Drug Administration (FDA) approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), a historic action making the first gene therapy available in the U.S., ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.

The FDA granted approval of Kymriah to Novartis Pharmaceuticals, and granted expanded approval of Actemra to Genentech.