▎WuXiEdited by Kant Content Team

Just now, Bristol Myers Squibb announced that the U.S. FDA has granted accelerated approval to Breyanzi (lisocabtagene maraleucel; liso-cel). This is a CD19-directed CAR-T cell therapy for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).Patients who have previously received at least two lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. The press release noted,This cellular therapy is the first CAR-T cell therapy for adult patients with relapsed or refractory CLL or SLL.

CLL is the most common type of leukemia in adults and is characterized by repeated relapses. CLL affects white blood cells or lymphocytes in the bone marrow, and the proliferation of cancer cells in the bone marrow leads to a reduced ability to fight infections. These cells spread into the bloodstream, affecting other parts of the body, including lymph nodes, liver, and spleen. SLL is a type of non-Hodgkin lymphoma that primarily impacts B lymphocytes in the immune system. SLL shares many similarities with CLL, but its tumor cells are more commonly found in the lymph nodes.

Breyanzi is an autologous CAR-T cell therapy targeting the CD19 antigen, with a defined composition and 4-1BB co-stimulatory domain.It was approved by the FDA in February 2021 for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) who have received two or more systemic therapies.The uniqueness of this therapy lies in the controlled ratio of CD8-positive and CD4-positive T cells in the CAR-T therapy, which can better manage the toxic side effects of the cell therapy.The 4-1BB signaling domain enhances the expansion and persistence of CAR-T cells.

According to the press release,This indication is approved based on the response rate and duration of response.The further approval of this indication may depend on the validation results of clinical efficacy in confirmatory trials.

The TRANSCEND CLL 004 trial, on which this approval was based, is an open-label, single-arm, multi-center clinical Phase 1/2 trial.Data analysis shows that the trial has reached its primary endpoint,20% received BreyPatients with relapsed or refractory CLL or SLL treated with anzi achieved complete response (CR), and safety has been confirmed.

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