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Breyanzi FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

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 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

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.