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FDA Approvals, News & UpdatesLymphoma

FDA Approved Breyanzi, Novel Gene Therapy, for Large B-Cell Lymphoma

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.
April 2021 Vol 7 No 2

In February 2021, the FDA approved Breyanzi (lisocabtagene maraleucel; from Juno Therapeutics), a new CAR T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma after 2 or more lines of systemic therapy.

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.

This approval was based on data from the TRANSCEND clinical trial of 192 adults with relapsed or refractory large B-cell lymphoma who had received chemotherapy and 2 or more lines of therapy.

The overall response rate was 73%, including 54% complete responses (remissions). The average time to first response was 1 month. Among patients who had a complete response, the responses lasted 6 months or longer in 65% of patients and 9 months or longer in 62% of patients.

The most common side effect was cytokine release syndrome (a potentially life-threatening condition), and 35% of all patients had a neurologic adverse event, including 3 fatal cases.

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Last modified: April 28, 2021

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