FDA has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor CAR T-cell therapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
Rick Pazdur’s appointment as director of the FDA’s Center for Drug Evaluation and Research (CDER) comes at exactly the right moment, both for the agency and for the patients it serves.
