NEW YORK – The US Food and Drug Administration on Thursday approved Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) in patients with relapsed or refractory mantle cell lymphoma.
The agency approved the CD19-directed CAR T-cell therapy for mantle cell lymphoma patients who previously received at least two prior lines of therapy, including a BTK inhibitor. The FDA based its approval on the results of the mantle cell lymphoma cohort within the Phase I TRANSCEND NHL 001 clinical trial in which 85.3 percent of efficacy-evaluable patients responded to Breyanzi and 67.6 percent achieved a complete response. After a median follow-up of 22.2 months, the median duration of response was 13.3 months.
Earlier this month, BMS nabbed FDA accelerated approval for Breyanzi in follicular lymphoma.
The cell therapy is also approved in the US, Japan, and Europe as second- or later-line treatment for certain large B-cell lymphoma patients. It is also approved in the US, Japan, Europe, Switzerland, the UK, and Canada in relapsed and refractory LBCL after two or more lines of systemic therapy. In March, the treatment also netted FDA accelerated approval as a third- or later-line treatment for chronic lymphocytic leukemia or small lymphocytic leukemia.