Yan Leyfman: FDA Accepts Bristol Myers Squibb’s Breyanzi for Priority Review as a Potential Treatment for Relapsed MZL
Yan Leyfman, Co-Founder and Executive Director of MedNews Week, shared a post on LinkedIn:
“FDA Priority Review Alert
Bristol Myers Squibb’s Breyanzi® (lisocabtagene maraleucel; liso-cel) has been accepted by the FDA for Priority Review as a potential treatment for relapsed or refractory marginal zone lymphoma (MZL) in adults who have received ≥2 prior lines of systemic therapy.
If approved, Breyanzi could become the first and only CAR T cell therapy for MZL, offering a much-needed option for patients who often face multiple relapses over the course of their disease.
Data driving the application:
Based on results from the MZL cohort of the Phase 2 TRANSCEND FL trial
Presented at ICML 2025 (oral session)
Showed high, durable response rates and a consistent safety profile
This milestone builds on recent FDA decisions to streamline patient monitoring and remove the REMS program for Breyanzi—key steps toward improving access and adoption of CAR T cell therapy.
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