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FDA Accepts BMS's sBLA for Breyanzi in Certain Leukemias, Lymphomas

NEW YORK – Bristol Myers Squibb said on Thursday that the US Food and Drug Administration accepted its supplemental biologics license application for Breyanzi (lisocabtagene maraleucel) to expand its indication to include the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor treatment.

The FDA granted priority review to the application and set a Prescription Drug User Fee Act (PDUFA) goal date of March 14, 2024.

The sBLA was based on results from the Phase I/II TRANSCEND CLL 004 trial. In results presented earlier this year from the study, overall response rate was 42.9 percent, and the median duration of response was 35.3 months for CLL or SLL patients on Breyanzi. Among 49 patients who had progressed on prior Bruton tyrosine kinase (BTK) and B-cell lymphoma 2 (BCL2) inhibitors, 63.3 percent had undetectable minimal residual disease in the blood and 59.2 percent in the bone marrow after receiving Breyanzi.

"Currently, there is no standard of care for people living with relapsed or refractory CLL or SLL after treatment with BTK inhibitor- and BCL2 inhibitor-based regimens, leaving a critical unmet need for a treatment option that provides deep and lasting responses," Anne Kerber, head of late clinical development, hematology, oncology, cell therapy at Bristol Myers Squibb, said in a statement. "This FDA acceptance brings us one step closer to offering these patients, for the first time, a personalized, T-cell based treatment option."

Breyanzi, a CD19-directed autologous CAR T-cell therapy, is currently approved in the US as a treatment for large B-cell lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal LBCL, and refractory follicular lymphoma.