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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
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Intermittent intravenous (IV) infusion is a method of drug administration where medications are delivered over short infusion periods followed by intervals of no drug delivery. This approach helps to prevent sustained high drug concentrations in the bloodstream, reducing the risk of adverse effects associated with prolonged exposure. Unlike continuous infusion, steady-state concentrations may not be achieved during a single dosing cycle but can be reached through repeated...
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A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...

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Updated: Jul 8, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
06:37

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

Epcoritamab Step-Up Dosing Regimen Selection and Optimization Using Repeated Time-to-Event Modeling for Cytokine

Tommy Li1, Andrew Tredennick2, Daniel Polhamus2

  • 1Genmab, Princeton, New Jersey, USA.

Clinical Pharmacology and Therapeutics
|July 7, 2026
PubMed
Summary
This summary is machine-generated.

Optimized dosing and supportive care with epcoritamab reduce cytokine release syndrome (CRS) risk in lymphoma patients. Dexamethasone and step-up dosing strategies further mitigate CRS, ensuring treatment safety.

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Last Updated: Jul 8, 2026

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
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Published on: February 17, 2022

Area of Science:

  • Hematology
  • Pharmacology
  • Oncology

Background:

  • Epcoritamab is an approved bispecific antibody for relapsed/refractory large B-cell lymphoma (LBCL) and follicular lymphoma (FL).
  • Cytokine release syndrome (CRS) is a significant toxicity associated with T-cell engaging therapies like epcoritamab.
  • Optimizing dosing and supportive care are crucial for managing CRS risk.

Purpose of the Study:

  • To develop and calibrate time-to-event models to assess CRS risk factors.
  • To evaluate the impact of step-up dosing (SUD) regimens and supportive care (fluids, corticosteroids) on CRS.
  • To compare the efficacy of dexamethasone versus prednisone in reducing CRS risk.

Main Methods:

  • Utilized pooled data from 600 patients with aggressive non-Hodgkin lymphoma (aNHL) and indolent NHL (iNHL) from EPCORE® NHL-1 and NHL-3 studies.
  • Developed and calibrated repeated time-to-event models to analyze CRS risk.
  • Assessed the influence of prior CAR T-cell therapy, intravenous fluids, and dexamethasone on CRS and epcoritamab's effective concentration.

Main Results:

  • Prior CAR T-cell therapy was associated with a 69.7% reduction in the maximum stimulatory effect on CRS hazard.
  • Intravenous fluids or dexamethasone during Cycle 1 increased epcoritamab's half-maximal effective concentration (S50) by 2.89-fold.
  • Prophylaxis with fluids and dexamethasone increased S50 by 3.79-fold, and dexamethasone further reduced CRS risk compared to prednisone.

Conclusions:

  • The approved 2-SUD regimen for R/R LBCL and 3-SUD regimen for R/R FL are adequate for managing CRS risk.
  • Intravenous fluids and dexamethasone prophylaxis are effective in reducing Grade ≥2 CRS.
  • Model-based simulations support optimized dosing and supportive care strategies for safe epcoritamab treatment.