FDA approved Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.
