Shots:
- The EC has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with r/r mantle cell lymphoma (MCL) after ≥2L of systemic therapy, incl. a BTK inhibitor, in all 30 EEA states
- Approval was based on the MCL cohort of the P-I (TRANSCEND NHL 001) trial assessing Breyanzi in adults with r/r B-cell non-Hodgkin lymphoma, incl. diffuse large B-cell lymphoma (BCL), high-grade BCL, primary mediastinal BCL, follicular lymphoma Grade 3B & MCL
- Trial met its 1 & 2EPs in 3L+ pts, with an ORR of 82.7% & CR rate of 71.6%. Responses were rapid, with a median time to first response of 0.95mos. & were durable, with 41.2% pts maintaining response at 24mos.
Ref: BMS | Image: BMS | Press Release
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