Breyanzi (lisocabtagene maraleucel): FDA-Approved Fourth CAR-T Therapy for Relapsed or Refractory Large B-Cell Lymphoma

The U.S. FDA Announces Approval of Breyanzi (lisocabtagene maraleucel), a CAR-T Therapy Developed by Juno Therapeutics, a Bristol-Myers Squibb (BMS) Subsidiary, for the Treatment of Adult Patients with Certain Large B-Cell Lymphomas Who Have Not Responded to at Least Two Other Systemic Therapies or Who Have Relapsed After Treatment. Breyanzi is a CD19-targeted CAR-T cell therapy and the fourth CAR-T therapy approved by the FDA.

Diffuse large B-cell lymphoma (DLBCL) is the most common malignant lymphoma worldwide and an aggressive form of non-Hodgkin lymphoma (NHL). Approximately 30% to 40% of patients with DLBCL fail to achieve remission after first-line therapy or experience disease relapse. Patients who are ineligible for first-line therapy and unsuitable for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) have a poor prognosis and urgently require additional treatment options.

Breyanzi is an autologous CAR-T therapy targeting the CD19 antigen. It has been granted Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA. The uniqueness of this therapy lies in the controlled ratio of CD8-positive to CD4-positive T cells within the CAR-T product, thereby enabling better management of the therapy’s toxicity and side effects.

This application is based on efficacy and safety data from the clinical trial named TRANSCEND NHL 001. The trial results demonstrated that among more than 250 evaluable patients, 54% achieved complete response (CR).

“Today’s approval represents another milestone in the field of gene therapy, providing additional treatment options for patients with certain cancers affecting the blood, bone marrow, and lymph nodes,” said Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “Gene and cell therapies have evolved from promising concepts into practical cancer treatment options.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma. Retrieved February 5, 2021, from https://www.prnewswire.com/news-releases/fda-approves-new-treatment-for-adults-with-relapsed-or-refractory-large-b-cell-lymphoma-301223275.html

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