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Viktig sikkerhets-og forskrivningsinformasjon: Breyanzi® (lisocabtagene maraleucel)

January 2026

Breyanzi in outpatient treatment of R/RLBCL1

OUTREACH is an open-label, multicenter, phase 2 study primarily evaluating the safety of Breyanzi as third-line or later treatment in patients with R/RLBCL at community medical centers in the United States across outpatient and inpatient settings.

At a median follow-up of 10.6 months, the rates of grade ≥3 adverse events were as follows: CR.S, 0% in both outpatients and inpatients; neurologic events, 12% and 4%; infections, 12% and 8%; and prolonged cytopenia, 33% and 32%, respectively.

Among all Breyanzi-treated patients, the overall response rate (ORR) was 80% (n = 66;95% CI, 70.3–88.4), and results were similar between outpatients (82%; 95% CI, 70.1–91.3) and inpatients (76%; 95% CI, 54.9–90.6). Progression-free survival (PFS), a secondary outcome, was also comparable between inpatient and outpatient groups, as shown below.

Conclusion: Breyanzi treatment at community sites with outpatient monitoring demonstrated high response rates, manageable safety, and feasibility in appropriately selected patients using standard procedures.

Text in English, reading time approximately 10 minutes

Breyanzi is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

References:

  1. Linhares et al, Blood Advances 2024, Volume 8, number 23

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2009-NO-2500020 Dec 2025