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FDA Grants Accelerated Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory CLL, SLL


CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.

Image credit: Aquir | stock.adobe.com

Image credit: Aquir | stock.adobe.com

The FDA has granted accelerated approval to Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were previously administered at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.1,2

Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T-cell therapy that is made from a patient’s own T cells. The cells are taken from a patient and genetically reengineered to become CAR T cells, which are subsequently infused back into the patient as a one-time treatment. The FDA granted Priority Review status to a supplemental Biologics License Application seeking to expand the current indication of Breyanzi in November 2023.3

“CAR T-cell therapies represent a transformative treatment option for patients with certain types of blood cancers,” Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, Bristol Myers Squibb, said in a press release. “For years, attempts to bring other CAR T cell therapies to patients with relapsed or refractory CLL or SLL met challenges and found little success. With the approval of Breyanzi as the first CAR T for relapsed or refractory CLL or SLL, we are now able to offer these patients a personalized option, while further expanding access across the broadest array of B-cell malignancies, to address this critical unmet need.”1

The FDA has previously approved Breyanzi to treat adults with large B-cell lymphoma (LBCL), including diffuse LBCL that is not otherwise specified; high-grade B-cell lymphoma; primary mediastinal LBCL; and patients with follicular lymphoma grade 3B whose disease is refractory to first-line chemoimmunotherapy or who relapse within 12 months of first-line chemoimmunotherapy, or disease that is refractory to first-line chemoimmunotherapy or relapse following first-line chemoimmunotherapy and who are not eligible for hematopoietic stem cell transplant because of comorbidities, age, or relapsed or refractory disease following two or more lines of systemic therapy.

The latest approval was based on response rate and duration of response (DOR) findings from the open-label, multicenter, single-arm Phase I/II TRANSCEND CLL 004 study (NCT03331198). Investigators enrolled adults with relapsed or refractory CLL or SLL who were previously administered at least two lines of therapy that included a BTK inhibitor and a BCL-2 inhibitor. The trial’s primary efficacy outcome measures included objective response rate (ORR), including complete response (CR) and partial response rates, and DOR per independent review committee assessment.

Data show that Breyanzi produced a CR rate of 20% and at the data cutoff date, patients who achieved the CR had a median DOR that had yet to be reached, with a 12-month DOR rate of 100% and an 18-month rate of 87.5%. ORR in patients administered Breyanzi was 45% with a median DOR of 35.3 months. Median time to first response was 1.1 months and median time to first CR was 3.0 months.

In terms of safety, 60% of patients experienced serious toxicities and 1.1% experienced fatal adverse effects (AEs).

“CLL and SLL are currently considered incurable diseases with few treatment options in the relapsed setting that can confer complete responses, something that has historically been associated with improved long-term outcomes,” lead investigator Tanya Siddiqi, MD, associate professor, Division of Lymphoma, City of Hope National Medical Center, said in a press release. “The FDA approval of [Breyanzi] in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL2i is a remarkable breakthrough, shifting the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance, to a one-time personalized T-cell based approach that has the potential to offer patients complete and lasting remission.”1


1. US FDA approves Bristol Myers Squibb’s Breyanzi ® as the first and only CAR T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). News release. Bristol Myers Squibb. March 14, 2024. Accessed March 15, 2024. https://news.bms.com/news/details/2024/U.S.-FDA-Approves-Bristol-Myers-Squibbs-Breyanzi--as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx

2. Breyanzi. Prescribing information. Bristol Myers Squibb; 2024. Accessed March 15, 2024. https://packageinserts.bms.com/pi/pi_breyanzi.pdf

3. U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel)for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Bristol Myers Squibb. November 9, 2023. Accessed March 15, 2024. https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Breyanzi-lisocabtagene-maraleucelfor-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx

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