Bristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi

The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb (BMS)’s Breyanzi (Lisocabtagene maraleucel) as the first CAR T cell therapy for adults with marginal zone lymphoma (MZL).

Authorised for a total of five cancer types in the US, Breyanzi’s latest indication is for MZL patients who have failed treatment or relapsed following two or more prior lines of therapy.

Lynelle Hoch, President, Cell Therapy Organization at Bristol Myers Squibb, said the FDA’s approval “further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients”.

This latest approval of Breyanzi is based on results from the MZL cohort in the phase II TRANSCEND FL trial. Of the patients who received Breyanzi as a single infusion, 95.5 percent responded, with 62.1 percent experiencing a complete response. These outcomes were durable following a median follow up of 21.6 months.

Dr Vijay Kumar, Acting Director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research (CBER), said that FDA’s approval considered “the high and durable response rate following a one-time treatment in patients with MZL, almost half of whom had either progression within two years of diagnosis or had refractory disease”.

These findings are important because, according to Dr Lia Palomba, TRANSCEND FL study investigator, patients “generally see success with initial therapy, but a subset of patients ultimately experience multiple relapses over the course of many years, creating a pressing need for new treatment options with durable outcomes”.

Dr Vinay Prasad, MPH, Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research (CBER) said the approval “represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL”.

The FDA granted approval of Breyanzi to Juno Therapeutics, Inc. Celgene acquired Juno Therapeutics in 2018, with BMS later completing its acquisition of Celgene in 2019.

Breyanzi is authorised to treat four other cancer types: large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma and mantle cell lymphoma.

In the EU, the European Commission authorised the CAR T therapy for lymphoma in 2023.