Following an expedited walk along the priority review path, Bristol Myers Squibb has announced that its CAR T cell therapy, Breyanzi (lisocabtagene maraleucel; liso-cel), has been awarded US Food and Drug Administration (FDA) accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Breyanzi is a CD19-directed chimeric antigen receptor (CAR)-T cell therapy designed to be administered intravenously as a one-time infusion to patients who have failed to respond to at least two prior lines of therapy, including a BTK inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
The approval was based on the response rate and duration of response seen in the Phase I/II TRANSCEND CLL 004 study (NCT03331198). As per the 14 March press release, 20% of patients treated with Breyanzi achieved a complete response (CR) while the median duration of response among those patients was not yet reached. In addition, the mediation duration of response among all responders was 35.3 months.
As per data presented at the 2023 American Society of Clinical Oncology (ASCO), an independent review committee (IRC) found that 9% of patients had grade 3 cytokine release syndrome, with no grade 4 or 5 cytokine release syndrome occurring in the same trial. This along with the efficacy would make Breyanzi a “strong therapeutic candidate” for r/r CLL/SLL patients, a GlobalData analyst said after the conference.
Breyanzi is the first and only cell immunotherapy to enter the CLL and SLL treatment space, which is dominated by BTK inhibitors such as Lilly’s Jaypirca (pirtobrutinib, 100mg and 50mg tablets), which received FDA approval for the indication in December 2023. Also carving out room in the indication is BeiGene’s Brukinsa (zanubrutinib), which gained UK approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat CLL and marginal zone lymphoma (MZL).
Patients living with the disease have limited treatment options, said Dr. Brian Koffman, executive VP and CMO of CLL Society in the press announcement. “The approval of Breyanzi as the first CAR T cell therapy available for relapsed or refractory CLL or SLL brings new hope to these patients with the potential for durable responses after a single CAR T infusion,” he added.
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By GlobalData
The therapy is also approved in the US as a second-line treatment for relapsed or refractory large B-cell lymphoma (LBCL) and outside the US as therapy for LBCL that has persisted following two or more lines of systemic therapy. An FDA-mandated boxed warning was added to the therapy’s label following an investigation on secondary cancer risks with CAR-T cell treatments.
According to GlobalData’s consensus forecast, Breyanzi is expected to generate over $1.9bn in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
