Tisagenlecleucel for Acute Lymphoblastic Leukemia

The FDA granted regular approval to tisagenlecleucel (Kymriah, Novartis) for the treatment of ALL that is refractory or in relapse in patients up to age 25.1 Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell immunotherapy agent. Efficacy Approval was based on a single-arm trial of 63 pediatric patients with precursor B-cell ALL.3 Patients received a single dose of tisagenlecleucel intravenously within 2 to 14 days following completion of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Safety The most common side effects include: cytokine-release syndrome (CRS) (79%), hypogammaglobulinemia (43%), infections (41%), pyrexia (40%), decreased appetite (37%), headache (37%), encephalopathy (34%), hypotension (31%), and bleeding disorders (31%).