The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines of therapy. This marks the first indication extension for a CAR-T product and adds to Breyanzi’s existing approval for the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL).
The FDA’s decision was supported by Phase I/II clinical data, which demonstrated that the CD19-directed therapy achieved a complete response (CR) rate of 20%, an objective response rate (ORR) of 45%, and a median duration of response of 35.3 months. While cytokine release syndrome (CRS) and neurologic events (NEs) were observed in 83% and 46% of patients respectively, grade 3 or higher occurrences were noted in only 9% and 21% of participants respectively.- Flcube.com
