Dr. Miklos on Alternative Options to KTE-X19 in MCL, While Awaiting FDA Decision

David Miklos, MD, associate professor of medicine, Blood and Marrow Transplantation, and clinical director of Cancer Cell Therapy at Stanford University Medical Center, discusses alternative options to the investigational CAR T-cell therapy KTE-X19 for patients with relapsed/refractory mantle cell lymphoma (MCL), while awaiting a regulatory decision from the FDA.

In February 2020, the FDA granted a priority review designation to a biologics license application (BLA) for KTE-X19 as a treatment in adult patients with relapsed/refractory MCL based on data from the phase 2 ZUMA-2 trial.

While awaiting the FDA’s decision regarding indication, price, etc., an expanded access trial is open at the same centers that in which the ZUMA-2 trial was conducted. Patients can be referred to those centers at this time and they will then be treated on a trial with close data acquisition for both clinical and adverse event collection, says Miklos. While awaiting the FDA’s decision, there is a bridge to help patients who are intolerant or refractory to BTK inhibition. Very few options are currently available to this patient population, concludes Miklos.