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Breyanzi

The European Commission Approves Breyanzi for Relapsed/Refractory Mantle Cell Lymphoma

The European Commission has approved lisocabtagene maraleucel (Breyanzi), a CD19-directed CAR T-cell therapy, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy, including a BTK inhibitor. This decision applies to all EU member states and EEA countries (Iceland, Norway, Liechtenstein).

Why this matters

Mantle cell lymphoma is a rare, aggressive B-cell non-Hodgkin lymphoma, accounting for ~3% of NHL cases, typically diagnosed in older adults and characterized by frequent relapse and treatment resistance.

After BTK inhibitors fail, options are limited and prognosis is poor, so an additional CAR T option in this space addresses a clear high-risk population.

Breyanzi

Key efficacy data – TRANSCEND NHL 001 (MCL cohort)

Approval is based on the MCL cohort of the TRANSCEND NHL 001 trial, which enrolled adults with r/r MCL after ≥2 prior lines, including a BTK inhibitor. Patients received a single Breyanzi infusion after lymphodepleting chemotherapy.

Responses

  • Overall response rate (ORR): 82.7% (95% CI 72.7–90.2)
  • Complete response (CR) rate: 71.6% (95% CI 60.5–81.1)
  • Median time to first response (CR or PR): 0.95 months (range 0.7–3.0)
  • At 24 months, 50.8% of patients remained in response, indicating durable benefit for a substantial proportion of this heavily pretreated group.

These results are notable given how refractory BTK-exposed MCL typically behaves and position Breyanzi as a high-depth, relatively rapid-onset option.

Breyanzi

Safety profile

The safety findings in MCL were consistent with the established CAR T safety profile seen with Breyanzi in other large B-cell lymphomas:

Cytokine release syndrome (CRS):

  • Any grade: 61%
  • Grade 3–4: 1%
  • Median time to onset: 4 days (range 1–10 days)

Neurologic toxicities (ICANS and others):

  • Any grade: 31%
  • Grade 3–4: 9%
  • Median time to onset: 8 days (range 1–25 days)

Most CRS and neuro events occurred within the first 2 weeks post-infusion and were generally reversible with appropriate management, supporting current practice of early, intensive monitoring in CAR T centers.

Clinical takeaways

  • Target population: Adults with r/r MCL after ≥2 lines including a BTKi — a group with high unmet need and limited curative options.
  • Efficacy: High ORR (82.7%) and CR rate (71.6%) with ~50% of patients still in response at 2 years suggest meaningful long-term disease control for many.
  • Safety: Predictable CAR T-type toxicities (CRS, neurotoxicity) with relatively low rates of grade ≥3 CRS and manageable timing, supporting use in experienced centers.
  • Practice impact: Breyanzi adds another CD19 CAR T option for post-BTKi MCL in Europe and may shift treatment algorithms toward earlier referral for cellular therapy in eligible patients.
Breyanzi CAR T-cell therapy lisocabtagene maraleucel TRANSCEND NHL 001