FDA Approves Breyanzi for Relapsed, Refractory Follicular Lymphoma


The Food and Drug Administration approved Breyanzi for patients with pretreated, relapsed or refractory follicular lymphoma.

The Food and Drug Administration (FDA) approved Breyanzi (lisocabtagene maraleucel) for the treatment of patients with relapsed or refractory follicular lymphoma who have previously been treated with two or more lines of therapy, according to an announcement from the agency.

“Today’s approval of Breyanzi for relapsed or refractory [follicular lymphoma] provides an option with potential for lasting remission in a one-time infusion and a safety profile that allows for administration and monitoring in both the inpatient and outpatient setting in an increasing number of certified treatment centers in the U.S.," Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb, said in a company-issued press release.

The approval is based off findings from the phase 2 TRANSCEND-FL trial, which included patients who had been treated with two or more systemic therapies, including an anti-CD20 antibody and alkylating agent. To be eligible, patients had to have adequate bone marrow function and be able to perform their daily tasks independently.

One of main goals of the trial was to investigate the overall response rate (ORR), which is the percentage of patients whose disease shrunk (known as a partial response) or disappeared (known as a complete response). The ORR was 95.7%. The other main goal of TRANSCEND-FL was duration of response, which is how long patients live after treatment without complications from the disease. At a median follow-up of 16.8 months, the duration of response was not reached, as not enough patients experienced disease complications for the researchers to calculate an average.

“In the treatment of relapsed or refractory follicular lymphoma, patients often cycle through treatments with typically shorter responses with each new line of therapy. Those who have experienced early disease progression have notably poor prognosis,” said Dr. M. Lia Palomba, TRANSCEND investigator and lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center in New York. “The FDA approval of [Breyanzi] for patients with relapsed or refractory [follicular lymphoma] is an important advancement in addressing an ongoing unmet need in the [follicular lymphoma] treatment paradigm, providing patients a new option that has shown remarkably high response rates and an established safety profile.”

Breyanzi is a CAR-T cell therapy. This type of treatment works by extracting patients’ cells, engineering the T cells to find and fight cancer, growing them and then infusing them back into the patient. Before the infusion of the new cells, patients must undergo lymphodepletion, which kills off existing T cells remaining in the body.

READ MORE: Nurse Says CAR-T Cell Therapy is a ‘Mind-Blowing’ Advancement

The most common side effects that occurred in 20% or more of patients on the TRANSCEND-FL study included cytokine release syndrome (a potentially serious condition that includes a increase in inflammatory markers, called cytokines, in the blood), musculoskeletal pain, fatigue, constipation and fever.

“The lymphoma community has felt an urgent need for advancements in the treatment of relapsed or refractory follicular lymphoma,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation. “The approval of Breyanzi offers patients a new and meaningful treatment option that provides hope for lasting remission, and we are grateful to those who have contributed to this exciting milestone for patients.”

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