By Fineline Cube 
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. This marks the first and only CAR‑T cell therapy approved for this patient population.
Regulatory Milestone & Clinical Basis
| Attribute | Details |
|---|---|
| Company | Bristol-Myers Squibb (NYSE: BMY) |
| Product | Breyanzi (lisocabtagene maraleucel; liso-cel) |
| Regulatory Status | FDA approval for new indication |
| Indication | R/R marginal zone lymphoma (MZL) post ≥2 prior systemic therapies |
| Significance | First CAR‑T therapy approved in MZL |
Clinical Basis: TRANSCEND FL (MZL cohort) – open-label, multicenter, multi-cohort, single-arm study.
Efficacy Data: TRANSCEND FL MZL Cohort
| Parameter | Result | Statistical Analysis |
|---|---|---|
| Overall Response Rate (ORR) | 95.5% | 95% CI: 87.3–99.1 (n=66, primary efficacy set) |
| Complete Response (CR) Rate | 62.1% | 95% CI: 49.3–73.8 |
| Median Duration of Response (mDOR) | Not reached | 95% CI: 25.59–NR |
| Response at 24 months | 90.1% of responders | Remained in response |
Setting: Third-line plus treatment in patients with R/R MZL.
Safety Profile & Boxed WARNINGS
| Safety Aspect | Findings |
|---|---|
| Overall Safety | Consistent with prior Breyanzi trials in other indications |
| Boxed WARNINGS | Cytokine Release Syndrome (CRS), Neurologic Toxicities, Secondary Hematological Malignancies |
| Risk Management | REMS program required; monitoring guidelines unchanged |
Market Context & Strategic Implications
- MZL Market Size: ~3,000-5,000 US patients annually eligible for third-line therapy
- CAR‑T Adoption: Expands Breyanzi’s label into indolent lymphoma space beyond aggressive lymphomas
- Revenue Impact: Analysts estimate $300-500 million peak US sales potential for MZL indication
- Manufacturing: Leverages established Breyanzi supply chain and certified treatment centers
- Competitive Moat: First-mover advantage in MZL with no other CAR‑T competitors approved
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Breyanzi’s commercial launch timeline, market penetration, and revenue potential in MZL. Actual results may differ due to regulatory, competitive, and reimbursement uncertainties.-Fineline Info & Tech