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Breyanzi in outpatient treatment of R/RLBCL

Produktresumé för våra godkända läkemedel på FASS: 
Breyanzi® (lisokabtagen-maraleucel)  |  Inrebic® (fedratinib)  |  Reblozyl® (luspatercept)  |  Revlimid® (lenalidomid)

Nov 2025

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.

Advere Events
Progression-free survival

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

2009-SE-2500020 13 nov 2025

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