Bristol Myers Squibb (BMS) has announced that its CD19-directed CAR T cell therapy Breyanzi (lisocabtagene maraleucel) has been granted priority review by the US Food and Drug Administration (FDA) to treat marginal zone lymphoma (MZL).
The decision specifically applies to adults with relapsed or refractory MZL who have received at least two prior lines of systemic therapy.
Breyanzi will now benefit from an expedited evaluation process, potentially bringing the therapy to patients faster, with a target review date set for 5 December this year.
BMS’ application is based on results from the primary analysis of the MZL cohort in the phase 2 TRANSCEND FL, which demonstrated clinically meaningful benefits for Breyanzi-treated patients.
The overall response rate was 95.5%, with 62.1% of patients achieving a complete response and 88.6% maintaining a response at 24 months.
“As highlighted by the data at International Conference on Malignant Lymphoma, Breyanzi continues to cover the broadest patient eligibility of any CAR T for B-cell malignancies and demonstrates a safety profile consistent with clinical trials and in the real-world setting for approved indications,” Rosanna Ricafort, vice president, senior global programme lead for haematology and cell therapy at BMS, said when the company presented the data in June.
MZL accounts for around 7% of all non-Hodgkin lymphoma cases. Despite initial therapy often resulting in disease remission, relapse is common and sometimes occurs several times over many years.
BMS’ Breyanzi 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 therapy already holds approvals to treat certain cases of large B-cell lymphoma, chronic lymphocytic leukaemia, small lymphocytic lymphoma, follicular lymphoma and mantle cell lymphoma.
“While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,” Ricafort said in the company’s latest statement. “This FDA acceptance brings us one step closer to potentially standardising CAR T cell therapy as a treatment option for MZL…”