Bristol-Myers Squibb Company — Breyanzi EMA EPAR variation assessment report (EMEA/H/C/004731, 2022)

Bristol-Myers Squibb Company · 2022 · EMA EPAR variation assessment report · company profile →

Report summary

This report summarizes a Type II variation application for Breyanzi (lisocabtagene maraleucel) to treat adult patients with 3rd line+ follicular lymphoma (FL), based on the pivotal Phase 2 TRANSCEND-FL study (JCAR017-FOL-001). The study demonstrated high overall and complete response rates, with durable responses, addressing the need for more efficacious treatments in R/R FL. Pharmacokinetic and pharmacodynamic profiles were analyzed, showing relationships between drug exposure and efficacy/safety. The safety profile of liso-cel, including cytokine release syndrome and neurotoxicity, was consistent with previous observations, with no new safety concerns identified over a median follow-up of 29.72 months. Supportive studies and indirect comparisons suggest favorable efficacy against existing therapies.

Key findings — cited to the page

Grade 3 or higher adverse reactions: neutropenia	61 %	FOL-001 · p.138
Grade 3 or higher adverse reactions: anaemia	10 %	FOL-001 · p.138
anaemia (any grade)	40 %	FOL-001 · p.138
constipation (any grade)	21 %	FOL-001 · p.138
Grade 3 or higher adverse reactions: lymphopenia	12 %	FOL-001 · p.138
Grade 3 or higher adverse reactions: thrombocytopenia	12 %	FOL-001 · p.138
neutropenia (any grade)	68 %	FOL-001 · p.138
CRS (any grade)	58 %	FOL-001 · p.138
headache (any grade)	29 %	FOL-001 · p.138
thrombocytopenia (any grade)	29 %	FOL-001 · p.138
Grade 3 or higher adverse reactions: leukopenia	12 %	FOL-001 · p.138
Grade 3 CRS incidence	0.8 %	FOL-001 · p.138

Source: Bristol-Myers Squibb Company ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →