Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Representing around 3% of all non-Hodgkin lymphoma (NHL) cases, MCL is a rare form of NHL that originates from cells in the mantle zone of the lymph node. For most patients, relapse after initial treatment is common and the disease eventually progresses or returns.
Already holding approvals for certain lymphomas, Breyanzi is a CD19-directed CAR T cell therapy that is designed using patients’ own T cells, which are collected and genetically re-engineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
The FDA approval was based on results from the MCL cohort of TRANSCEND NHL 001, which evaluated Breyanzi in adults with relapsed or refractory MCL who had previously received at least two or more prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Results demonstrated that more than 85% of patients responded to treatment and nearly 70% achieved a complete response (CR), while more than 51% of patients remained in response at 12 months and nearly 40% of responders remained in response at 18 months.
Additionally, primary analysis results published in the Journal of Clinical Oncology showed an overall response rate of more than 83%, a CR of over 72% and progression-free survival of over 15 months.
Lead investigator, Michael Wang, University of Texas MD Anderson Cancer Center, commented: “The approval of Breyanzi offers an important new CAR T treatment option with high rates of lasting responses and a consistent safety profile.”
Bryan Campbell, senior vice president, head of commercial, cell therapy, BMS, said: “We are delivering… a definitive treatment option for some of the most difficult-to-treat lymphomas.”
The recent approval is the fourth to be granted for Breyanzi for a subtype of NHL.
Most recently, in May, BMS’ CD19-directed CAR T cell therapy received accelerated approval by the FDA to treat follicular lymphoma, the second-most common form of NHL, accounting for up to 30% of all cases.