FDA Approves Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma

The FDA has approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, a Bristol Myers Squibb company) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi).

Efficacy was evaluated in TRANSCEND-MCL (ClinicalTrials.gov. Identifier: NCT02631044), an open-label, multicenter, single-arm trial in adult patients with relapsed or refractory MCL who had received at