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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

Jun 24, 2022Approval U.S. FDA Approves Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi for Relapsed or Refractory Large B-cell Lymphoma After One Prior Therapy
Feb  5, 2021Approval FDA Approves Breyanzi (lisocabtagene maraleucel) CAR-T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma
Nov 16, 2020Bristol Myers Squibb Provides Regulatory Update on Lisocabtagene Maraleucel (liso-cel)
May  6, 2020Bristol Myers Squibb Provides Update on Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel)
Feb 13, 2020U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma
Dec 18, 2019Bristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA
Dec  8, 2019Bristol-Myers Squibb Announces Liso-Cel Met Primary and Secondary Endpoints in TRANSCEND NHL 001 Study
Jun  4, 2019Celgene Announces Data from Ongoing Studies of Liso-Cel in Patients with Difficult-to-Treat Blood Cancers at ASCO 2019

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.