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FDA Approves New CAR-T Therapy for R/R Large B-Cell Lymphoma

On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics), a new CAR-T therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least 2 lines of systemic therapy.

This approval was based on data from a single-arm clinical trial involving 192 patients with relapsed or refractory large B-cell lymphoma given lisocabtagene maraleucel after at least 2 lines of therapy.

Findings showed an overall response (ORR) rate of 73% (95% CI, 67-80) and a complete response (CR) rate of 54% (95% CI, 47-61).

Of the 104 patients that achieved CR, 65% had remissions lasting at least 6 months and 62% had remissions lasting at least 9 months.

The estimated duration of response (DOR) for patients with CRs was not reached (95% CI, 16.7 months to not reached) but was 1.4 months (95% CI, 1.1-2.2) for those with partial responses.

Grade 3 or higher adverse reactions included cytokine release syndrome (46%), neurologic toxicity (35%), infections (19%), and prolonged cytopenias (31%). In 3 patients, fatal neurologic toxicity was reported.—Emily Bader

Source: US Food and Drug Administration. FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma. February 5, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-large-b-cell-lymphoma. Accessed February 9, 2021.

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