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Oncology Learning NetworkFDA Approval of Epcoritamab for Patients with R/R Diffuse Large B-Cell Lymphoma

Epcoritamab is approved for R/R DLBCL patients after ≥2 lines of previous therapy, including anti-CD20 monoclonal antibody therapy.

The recent FDA approval of epcoritamab for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) represents a significant advancement in treatment options. Associate Professor Dr. Tycel Jovelle Phillips provided insights into the function, efficacy, and potential impact of this novel bispecific CD20-directed CD3 T-cell engager in a recent discussion. Here are the main takeaways.

Key Points:

  • Mechanism: Binds CD3 to engage patient’s T-cells, then CD20 to induce malignant B-cell death.
  • Approval based on EPCORE™ NHL-1 study with an overall response rate of 60% and a complete response rate of 38%.
  • Durability observed with 89% of complete responders still in remission at initial study cutoff.
  • Safety profile: Incidence of cytokine release syndrome (CRS) around 51%, mostly grade 1 or 2, and only 2.5% grade 3; immune effector cell-associated neurotoxicity syndrome (ICANS) rare.

Additional Points:

  • Epcoritamab offers an off-the-shelf option, increasing accessibility compared to CAR-T.
  • Timing of CRS events essential for management, with 92% occurring during cycle 1.
  • Further investigation expected in outpatient treatment, combination with other therapies, and possible use in second-line settings.
  • Epcoritamab could be implemented in diverse patient populations and not restricted to academic centers.


  • The FDA approval of epcoritamab offers a promising new treatment pathway for R/R DLBCL patients, with the potential to expand accessibility beyond current CAR-T options, while maintaining an acceptable safety profile.

Hematology/Oncology Further Reading

“I think it’s an exciting time for patients and practitioners. I mean, to get our hands on this treatment will be, hopefully, quite beneficial. And as we all get more comfortable with using epcoritamab, then used to the side effects, I mean, I think it’ll be a boon for our patients.”

Dr. Tycel Phillips
Associate Professor
City of Hope National Medical Center
Duarte, California
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