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FDA approval
BMS’ Breyanzi receives FDA approval for mantle cell lymphoma
Cell & Gene Therapy
May 30, 2024
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Cell & Gene Therapy

Cell & Gene Therapy

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May 30, 2024

BMS’ Breyanzi receives FDA approval for mantle cell lymphoma

FDA approval

  • Bristol Myers Squibb (BMS) has received FDA approval for its one-time CAR T therapy, Breyanzi, to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have undergone a minimum of two lines of systemic therapy, inclusive of Bruton tyrosine kinase inhibitor.

  • This approval is based on Breyanzi’s performance in the TRANSCEND-NHL-001 study of patients with various types of relapsed or refractory B-cell non-Hodgkin lymphoma. Breyanzi demonstrated a highly consistent safety profile and high rates of lasting responses over 18 months.

  • Breyanzi reportedly marks the first CAR T therapy to receive FDA approval to treat four non-Hodgkin lymphoma subtypes, which include relapsed or refractory follicular lymphoma ( May 2024 ), chronic lymphocytic leukemia, and small lymphocytic lymphoma ( March 2024 ).

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