Bristol Myers Squibb’s CD19-directed CAR T cell therapy Breyanzi (lisocabtagene maraleucel) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat follicular lymphoma (FL).
The regulator’s decision specifically applies to adult patients with relapsed or refractory disease who have received at least two prior lines of systemic therapy.
FL is the second-most common form of non-Hodgkin lymphoma, accounting for up to 30% of all cases.
The disease has historically been considered incurable, with patients frequently relapsing following front-line therapy and the prognosis worsening after each subsequent relapse.
BMS noted that, despite advances in treatment, there remains an unmet need for additional options that offer treatment-free intervals with durable, complete responses.
The company’s Breyanzi already holds approvals to treat certain lymphomas and is made from 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’s latest approval of the therapy was supported by positive results from the mid-stage TRANSCEND FL study, which demonstrated an overall response rate of 95.7% in patients treated with Breyanzi in the third-line plus setting.
The complete response rate was 73.4%, with 80.9% of responders remaining in response at 12 months and 77.1% remaining in response at 18 months.
“In the treatment of relapsed or refractory FL, patients often cycle through treatments with typically shorter responses with each new line of therapy,” said TRANSCEND investigator Lia Palomba, Memorial Sloan Kettering Cancer Center.
Palomba added: “The FDA approval of [Breyanzi] for patients with relapsed or refractory FL is an important advancement in addressing an ongoing unmet need in the FL treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”
The authorisation comes just two months after the FDA granted accelerated approval to Breyanzi for use in adults with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.