FDA’s Advisory Committee Supports CTL019 in Pediatric, Young Adult Patients With B-Cell ALL
Today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the biologics license application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). The committee voted unanimously in favor of CTL019 for this indication.
CTL019 is an adoptive immunocellular cancer therapy using autologous peripheral blood T cells that have been reprogrammed with a transgene encoding a CAR to identify and eliminate CD19-expressing malignant and nonmalignant cells. The efficacy and safety of CTL019 have been evaluated in 3 trials involving over 150 pediatric and young adult patients with relapsed/refractory B-cell ALL, with a maximum follow-up extending to 40.5 months. The data were summarized and submitted to the FDA in February 2017.
A final decision from the FDA is expected later this year.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
