Breyanzi FDA Approval History
FDA Approved: Yes (First approved February 5, 2021)
Brand name: Breyanzi
Generic name: lisocabtagene maraleucel
Dosage form: Suspension for Intravenous Infusion
Company: Bristol-Myers Squibb Company
Treatment for: Large B-Cell Lymphoma
Breyanzi (lisocabtagene maraleucel) is a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).
- Breyanzi is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.
- The Breyanzi product label carries a boxed warning advising the risk of Cytokine Release Syndrome (CRS) and neurologic toxicities, which can be fatal or life-threatening. Breyanzi is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Breyanzi REMS.
- Breyanzi is administered via intravenous infusion in a certified healthcare facility.
- Breyanzi may cause serious adverse reactions including hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia and secondary malignancies.
- Patients receiving Breyanzi should refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery for at least 8 weeks.
- Common nonlaboratory adverse reactions include fatigue, cytokine release syndrome, musculoskeletal pain, nausea, headache, encephalopathy, infections, decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.
Development Timeline for Breyanzi
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