Epcoritamab: Revolutionizing Therapy for Diffuse Large B-cell Lymphoma

• FDA has granted accelerated approval for Epocoritamab.
• Efficacy is evaluated in EPCORE NHL 1.
• Application has granted for Priority Review.

SciFocus | December 22, 2023. The U.S. Food and Drug Administration has granted accelerated approval for Epcoritamab, a bispecific antibody, for Diffuse Large B-cell Lymphoma. It is marketed under the brand name Epkinly in the United States. Additionally, the European Commission has granted approval for Epcoritamab, which is sold under the name TEPKINLY [1]. Genmab developed Epocortimab utilizing its proprietary technology known as Duobody [2].

The evaluation of treatment efficacy utilized a clinical trial named EPCORE NHL-1, encompassing 148 patients. The results indicate that 61% of patients demonstrated an Overall Response Rate (ORR), with 38% achieving a complete response.

Epcortimab exhibits cytokine Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), leading to the inclusion of a boxed warning for this medication.

Epcortimab should exclusively be administered subcutaneously by healthcare professionals due to the potential risk of CRS and ICANS. This review employed the Assessment Aid and was also granted priority review [3].

References:

1. AbbVie Announces FDA and EMA Updates for Epcoritamab
2. https://www.genmab.com/research-innovation/antibody-technology-platforms/
3. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
4. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell

Author: Sarath Kumar

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