Breyanzi FDA Approval History
Last updated by Judith Stewart, BPharm on July 6, 2022.
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: Diffuse Large B-Cell Lymphoma
Breyanzi (lisocabtagene maraleucel) is a CD-19 directed 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 large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), highgrade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
- refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
- refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
- relapsed or refractory disease after two or more lines of systemic therapy.
- 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 fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. Common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
Development timeline for Breyanzi
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