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. follicular lymphoma & MZL
- In Breyanzi-treated MZL pts (n=66), ORR was 95.5%, with 62.1% achieving CR; at mFU of 21.6, 23.8, & 24.5mos. the DoR was 88.6%, PFS was 85.7% & OS rate was 90.4%, respectively, at 24mos.; data was presented at ICML 2025
Ref: BusinessWire | Image: BMS| Press Release
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