FDA Approves First CAR T-Cell Therapy for CLL and SLL

The FDA has approved the chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (marketed as Breyanzi) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The FDA’s approval requires patients to have tried at least 2 other lines of treatment, specifically a BTK inhibitor and a B-cell lymphoma 2 inhibitor. Breyanzi is now an option for patients whose CLL or SLL did not respond to prior treatment or returned after going into remission.

The CAR T-cell therapy Breyanzi is approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.

The National Cancer Institute says CLL and SLL are the same disease. The only difference is where cancer cells are found: CLL cells mostly in blood and bone marrow; SLL cells mostly in the lymph nodes. The 2 combine for approximately 18,000 new cases in the United States each year.

Breyanzi is a CD19-directed CAR T-cell therapy, which is a type of cancer cell and gene therapy that engineers immune system cells to more effectively look for and destroy tumors. Scientists create CAR T-cells by removing a patient’s T-cells and adding a protein receptor (called a CAR) that directs the T-cells to attack cancer cells expressing a specific protein.

The protein CD19 is found on the surface of CLL and SLL cells, making it a valuable target for CAR T-cells.

Breyanzi was already 1 of 6 CAR T-cell therapies approved for blood cancers. It was first approved by the FDA in 2021 to treat people with relapsed or resistant large B-cell lymphoma. This latest approval means Breyanzi is one of 2 CAR T-cell therapies—the other being tisagenlecleucel (Kymriah)—with approvals for indications of leukemia and lymphoma. The other approved CAR T-cell therapies are allowed for just 1 type of blood cancer.

Read more about this approval on the Alliance for Cancer Gene Therapy website.