BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots:The US FDA has accepted sBLA & granted priority review to Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy (PDUFA: Dec 5, 2025)sBLA is supported by the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl.…

ByRidhi RastogiAugust 5, 2025

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BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots:The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL In pts treated in 3L+ setting, study met…

ByRidhi RastogiMarch 17, 2025

BMS Reports the US FDA’s sBLA Acceptance and Priority Review of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

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