Breyanzi Indications
Breyanzi Indications
Introduction to Breyanzi
Product Name: Breyanzi
Generic Name: Lisocabtagene Maraleucel (liso-cel)
Target: CD19
Company: Bristol Myers Squibb (BMS), Juno Therapeutics
First Approval in the US: February 2021
First Approval in China: Not yet approved
Approved Indications: Relapsed/Refractory Large B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma, Mantle Cell Lymphoma
Approved time
On February 5, 2021, Breyanzi received approval from the US FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
On March 14, 2024, the US FDA granted accelerated approval for Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
On May 15, 2024, the US FDA granted accelerated approval for Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
On May 30, 2024, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s CD19-targeted CAR-T cell therapy Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). These patients had previously received at least two lines of systemic therapy, including a BTK inhibitor.
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