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News|Articles|April 1, 2026

FDA Revises Recommendation on First Full Epcoritamab Dose in R/R DLBCL to Allow Outpatient Monitoring

Author(s)Mary Caffrey
Fact checked by: Maggie L. Shaw
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Key Takeaways

  • FDA label revisions allow Cycle 1 Day 15 full-dose epcoritamab to be administered with outpatient monitoring rather than routine 24-hour inpatient observation in R/R DLBCL.
  • Interim EPCORE‑NHL‑6 findings support outpatient feasibility and safety when monitoring protocols are applied, informing real-world implementation of bispecific antibody step-up strategies.
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The FDA now permits outpatient monitoring for epcoritamab’s first full dose in R/R DLBCL, as EPCORE-NHL-6 data support safe bispecific antibody access.

Outpatient monitoring will be permitted for patients receiving epcoritamab (Epkinly; Genmab/AbbVie) under a new FDA approval, which updates the across-the-board recommendation for 24-hour hospitalization following the first full 48-mg dose that patients receive to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

The companies shared the updated product label in an email to The American Journal of Managed Care following the change. The label update comes days after data from EPCORE-NHL-6 (NCT05451810) showed that this first full dose, given in cycle 1, day 15, could be safely shifted to the outpatient setting with proper monitoring in most cases. Interim results from the study were published in Clinical Lymphoma, Myeloma and Leukemia.1

“Outpatient administration may remove barriers for some patients by facilitating treatment in more localized community-based clinics while reducing costs and caregiver demands,” the authors wrote.1

The FDA’s change aligns with a previously approved recommendation for administration of epcoritamab for follicular lymphoma (FL) on cycle 1, day 22.

Moving administration of bispecific antibodies into the outpatient setting is considered key to making these treatments accessible to as many patients as possible. This is especially true in DLCBL, as it is both a common blood cancer and an aggressive one, and it becomes harder to treat with each successive line of treatment. Epcoritamab is given by subcutaneous injection.

According to the Lymphoma Research Foundation, DLBCL accounts for 25% to 30% of cases of non-Hodgkin lymphoma globally, with approximately 18,000 to 30,000 new cases diagnosed in the US annually.2

References

  1. Andorsky D, Lopez A, Vaidya R, et al. Epcoritamab monotherapy as outpatient treatment for patients with relapsed/refractory diffuse large B-cell lymphoma: interim results from EPCORE NHL-6. Clin Lymphoma Myeloma Leuk. 2026;S2152-2650(26)00042-X. doi:10.1016/j.clml.2026.02.006
  2. Non-Hodgkin lymphoma. Lymphoma Research Foundation. Accessed April 13, 2026. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/

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