Epcoritamab* FDA approval timeline9
- May 2023 (accelerated approval): For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high grade B-cell lymphoma (HGBL) after 2 or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
AbbVie and Genmab continue to investigate Epcoritamab in ongoing Phase 3 and early phase clinical trials for the treatment of DLBLC, as well as other cancers, including follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL).
EPCORITIMAB INDICATION AND SAFETY OVERVIEW FOR DLBCL (US PRESCRIBING INFORMATION)9
Epcoritamab is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and durability of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving Epcoritamab. Initiate treatment with the Epcoritamab step-up dosing schedule to reduce the incidence and severity of CRS. With hold Epcoritamab until CRS resolves or permanently discontinue based on severity.
- Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening and fatal reactions, can occur with Epcoritamab. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold Epcoritamab until ICANS resolves or permanently discontinue based on severity.
Warnings & Precautions
- Infections: Can cause serious or fatal infections. Monitor patients for signs or symptoms of infection, including opportunistic infections, and treat appropriately.
- Cytopenias: Monitor complete blood cell counts during treatment.
- Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
The most common (≥ 20%) adverse reactions are cytokine release syndrome, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥ 10%) are decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
Use in Specific Populations
Lactation: Advise not to breastfeed.
Review full prescribing information for additional information at: https://www.genmab-pi.com/prescribing-information/epkinly-pi.pdf
View select clinical trials with epcoritamab now. To view a full list of clinical trials in which epcoritamab is being investigated, please visit ClinicalTrials.gov.
- Hutchings M, et al. Epcoritamab (GEN3013; DuoBody-CD3×CD20) to induce complete response in patients with relapsed/refractory B-cell non-Hodgkin lymphoma: Complete dose escalation data and efficacy results from a phase I/II trial. Poster #8009. 56th Annual ASCO Meeting and Exposition; May 29 – June 2, 2020; Virtual Format.
- Engelberts PJ, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625.
- Hutchings M, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021;398(10306):1157-1169
- ClinicalTrials.gov. NCT03625037. https://clinicaltrials.gov/ct2/show/NCT03625037. Accessed October 2020.
- EudraCT Number 2020-000845-15. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000845-15/DK/. Accessed November 2020.
- ClinicalTrials.gov. NCT04542824. https://clinicaltrials.gov/ct2/show/NCT04542824. Accessed October 2020.
- ClinicalTrials.gov. NCT04623541. https://clinicaltrials.gov/ct2/show/NCT04623541. Accessed November 2020.
- ClinicalTrials.gov. NCT04628494. https://clinicaltrials.gov/ct2/show/NCT04628494. Accessed November 2020.
- Epcoritamab [package insert]. North Chicago, IL; AbbVie, Inc. and Plainsboro, NJ: Genmab US, Inc.: May 2023.