FDA approves first CAR T-cell therapy for CLL and SLL.

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

The U.S. Food and Drug Administration (FDA) last week approved the CAR T-cell therapy lisocabtagene maraleucel (brand name Breyanzi) as a treatment for relapsed or resistant chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

CAR T-cell therapy, a type of cancer cell and gene therapy, uses immune system cells genetically engineered to look for and attack cancer cells expressing a specific protein. Breyanzi is engineered to target the protein CD19, which is often present on the surface of leukemia and lymphoma cells.

Breyanzi is the first cell and gene therapy approved to treat CLL and SLL, which account for approximately 18,700 new cases in the U.S. each year. The FDA’s approval requires that patients have tried at least two other lines of treatment, specifically a BTK inhibitor and a B-cell lymphoma 2 inhibitor, before receiving Breyanzi. 

In a recent phase 2 clinical trial, 45% of CLL and SLL patients had an anti-tumor response after receiving Breyanzi and 18.4% had a complete response (no sign of tumors on scans). Reported side effects for study participants were mostly low-grade or mild. 

Breyanzi, which is manufactured by Bristol Myers Squibb, is one of six CAR T-cell therapies approved for blood cancers. It was first approved in 2021 to treat people with relapsed or resistant large B-cell lymphoma. 

Read more about the approval on the CLL Society website or in the Bristol Myers Squibb press release.