At a July 2017 FDA Oncology Advisory Committee meeting, the panel reviewed Novartis’ CTL019 (tisagenlecleucel), an agent for aggressive pediatric and young adult acute B-cell acute lymphoblastic leukemia (ALL). The committee unanimously recommended its approval. On August 30, 2017, the FDA approved Kymriah (tisagenlecleucel), the first U.S. CAR-T cell therapy.
The second available CAR T agent, Kite/Gilead’s Yescarta (axicabtagene ciloleucel), also previously known as KTE-C19, was approved on October 18, 2017.
Specifically, Yescarta was approved in adult patients with large B-cell lymphoma after at least two other kinds of treatment failed. Lymphoma types include diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Of note, Kite Pharma, the original developer of KTE-C19, was bought by Gilead Pharmaceuticals in late August 2017 for close to $12 billion.
Learn More: CAR T-Cell Therapy: A Healthcare Professional’s Guide: KTE-C19 Studies
