Bristol Myers Squibb has secured the US Food and Drug Administration (FDA) approval for Breyanzi (lisocabtagene maraleucel; liso-cel) to treat a type of B-cell lymphoma.

The drug is indicated for the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy and is not indicated for patients with primary central nervous system lymphoma.

The indication includes diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy, with a defined composition and 4-1BB costimulatory domain.

Bristol Myers Squibb chief medical officer Samit Hirawat said: “Breyanzi, a CAR T cell therapy, will have an important role in clinical practice, offering people living with relapsed or refractory large B-cell lymphoma the chance for sustained response with an individualized treatment experience.

“Today’s FDA approval reflects our deep commitment to advancing cell therapy research, developing innovative treatments and supporting patients at every step of their treatment journey.”

The US FDA approved Breyanzi based on positive data from the TRANSCEND NHL 001 trial, which evaluated 268 patients with R/R LBCL.

In the study, treatment using Breyanzi showed 73% overall response rate and 54% complete response (CR) rate in 3L+ LBCL.

The most common nonlaboratory, serious adverse reactions include CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium.

TRANSCEND NHL 001 principal investigator Jeremy Abramson said: “In TRANSCEND NHL 001, Breyanzi produced sustained responses in a significant proportion of patients with relapsed or refractory large B-cell lymphoma.

“TRANSCEND also demonstrated feasibility of outpatient administration, which is meaningful for patients, physicians and the healthcare system.

“With this approval, we now have an important new treatment option for patients with relapsed or refractory large B-cell lymphoma who have undergone at least two prior lines of systemic therapy.”

Bristol Myers Squibb intends to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facility in Bothell, Washington.

The company is planning to launch Breyanzi across a wide network of treatment centres, which will be Risk Evaluation and Mitigation Strategy (REMS) certified to support the appropriate use of Breyanzi.

Healthcare facilities including hospitals and related outpatient clinics are required to enrol and comply with REMS requirements and training on the management of CRS and NT.

Bristol Myers Squibb is also providing Cell Therapy 360, a digital service platform to optimise access to related information, manufacturing updates, patient and caregiver support, and outpatient management resources to support patients.

The company will provide a disposable wearable technology for patients during the initial post-infusion monitoring period, to remotely track the temperature in real-time, when they are away from the treatment centre.

European Union granted Priority Medicines (PRIME) designation for Breyanzi for R/R DLBCL and the European Medicines Agency is currently reviewing its Marketing Authorization Application (MAA).