Bristol Myers Squibb Receives FDA Approval for Breyanzi in Chronic Lymphocytic Leukemia

Bristol Myers Squibb today announced that the FDA has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor. In the TRANSCEND CLL 004 trial, Breyanzi demonstrated an overall response rate of 45% and a complete response rate of 18% in heavily pretreated patients. Breyanzi is a CD19-directed CAR T-cell therapy. This approval provides a new cellular therapy option for patients with CLL/SLL who have exhausted other treatment options.