{"id":50029,"date":"2025-12-05T22:38:44","date_gmt":"2025-12-05T14:38:44","guid":{"rendered":"https:\/\/flcube.com\/?p=50029"},"modified":"2025-12-05T22:38:45","modified_gmt":"2025-12-05T14:38:45","slug":"bms-breyanzi-mzl-fda-approval-first-car-t","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50029","title":{"rendered":"BMS Breyanzi MZL FDA Approval First CAR-T"},"content":{"rendered":"\n

Bristol-Myers Squibb<\/strong> (BMS, NYSE: BMY<\/a>) announced that the FDA has approved Breyanzi<\/strong> (lisocabtagene maraleucel; liso-cel) for adult patients with relapsed or refractory (R\/R) marginal zone lymphoma (MZL)<\/strong> who have received at least two prior lines of systemic therapy. This marks the first and only CAR\u2011T cell therapy approved<\/strong> for this patient population.<\/p>\n\n\n\n

Regulatory Milestone & Clinical Basis<\/h2>\n\n\n\n
Attribute<\/th>Details<\/th><\/tr><\/thead>
Company<\/strong><\/td>Bristol-Myers Squibb (NYSE: BMY)<\/td><\/tr>
Product<\/strong><\/td>Breyanzi (lisocabtagene maraleucel; liso-cel)<\/td><\/tr>
Regulatory Status<\/strong><\/td>FDA approval for new indication<\/td><\/tr>
Indication<\/strong><\/td>R\/R marginal zone lymphoma (MZL) post \u22652 prior systemic therapies<\/td><\/tr>
Significance<\/strong><\/td>First CAR\u2011T therapy approved in MZL<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Basis:<\/strong> TRANSCEND FL (MZL cohort) \u2013 open-label, multicenter, multi-cohort, single-arm study.<\/p>\n\n\n\n

Efficacy Data: TRANSCEND FL MZL Cohort<\/h2>\n\n\n\n
Parameter<\/th>Result<\/th>Statistical Analysis<\/th><\/tr><\/thead>
Overall Response Rate (ORR)<\/strong><\/td>95.5%<\/td>95% CI: 87.3\u201399.1 (n=66, primary efficacy set)<\/td><\/tr>
Complete Response (CR) Rate<\/strong><\/td>62.1%<\/td>95% CI: 49.3\u201373.8<\/td><\/tr>
Median Duration of Response (mDOR)<\/strong><\/td>Not reached<\/td>95% CI: 25.59\u2013NR<\/td><\/tr>
Response at 24 months<\/strong><\/td>90.1% of responders<\/td>Remained in response<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Setting:<\/strong> Third-line plus treatment in patients with R\/R MZL.<\/p>\n\n\n\n

Safety Profile & Boxed WARNINGS<\/h2>\n\n\n\n
Safety Aspect<\/th>Findings<\/th><\/tr><\/thead>
Overall Safety<\/strong><\/td>Consistent with prior Breyanzi trials in other indications<\/td><\/tr>
Boxed WARNINGS<\/strong><\/td>Cytokine Release Syndrome (CRS), Neurologic Toxicities, Secondary Hematological Malignancies<\/td><\/tr>
Risk Management<\/strong><\/td>REMS program required; monitoring guidelines unchanged<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Strategic Implications<\/h2>\n\n\n\n