The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two prior lines of systemic therapy. Breyanzi is also indicated for other relapsed or refractory forms of non-Hodgkin lymphoma (NHL), including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, and follicular lymphoma (FL).
The FDA’s decision is supported by Phase I data which demonstrated an overall response rate (ORR) of 83.1%, a complete response rate (CRR) of 72.3%, a median duration of response of 15.7 months, and a progression-free survival (PFS) of 15.3 months.- Flcube.com
