License for a CAR T: Examining patient eligibility

Abstract

Chimeric antigen receptor (CAR) T-cell therapy has transformed the treatment landscape of lymphoma and is now approved by the FDA for multiple indications. Given that the indications for CAR T-cell therapy are expanding, a larger patient population will be eligible to receive this treatment in the coming years. Pivotal clinical trials leading to FDA approval of CAR T-cell products required patients to have adequate organ function and good performance status. In the real world, however, the patient population eligible for CAR T-cell therapy includes patients who are older, frail, have poor performance status, and have multiple comorbidities. Studies have shown that CAR T-cell therapy is relatively safe and tolerable in such frail patients, however, there is no agreed upon consensus or guidelines to assess eligibility for CAR T-cell therapy at this moment. Gaining further insight into such patient populations will be vital in order to safely provide and expand access to CAR T-cell therapy.