The FDA has granted orphan drug designation to the next generation BCMA-directed CAR T-cell therapy NXC-201 for the treatment of patients with amyloid light chain amyloidosis.
Morie A. Gertz, MD, discusses the rationale for the phase 3 AFFIRM-AL trial in patients with amyloid light chain amyloidosis and elaborates on the challenges that may arise when enrolling patients to this trial.