Epcoritamab Granted FDA Priority Review for Relapsed or Refractory Follicular Lymphoma with 82% Overall Response Rate

Feb 28, 2024 08:05 CST Updated 08:05

Genmab

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AbbVie

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▎WuXiEdited by Kant Content Team

AbbVie and Genmab Jointly Announce FDA Acceptance of sBLA for Epcoritamab, Granted Priority Review for Treatment of R/R Follicular Lymphoma

The submission of this sBLA is primarily based on the results of the Phase 1/2 EPCORE NHL-1 clinical trial, which demonstrated high overall and complete response rates in R/R FL patients treated with epcoritamab. This open-label clinical trial enrolled a total of 128 R/R FL patients who had received at least two prior lines of systemic therapy, with 70.3% of the patients exhibiting dual resistance to anti-CD20 monoclonal antibodies and alkylating agents. Previously announced top-line results showed,According to the assessment by the Independent Review Committee, the overall response rate reached 82%, exceeding the pre-specified efficacy threshold.

Epcoritamab is a subcutaneously administered IgG1-subtype bispecific antibody constructed using Genmab's proprietary DuoBody technology.Genmab's DuoBody-CD3 technology is designed to selectively direct cytotoxic T cells to generate an immune response toward target cell types. It simultaneously binds to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20-positive cells. Epcoritamab received its first approval from the U.S. FDA in May of last year.Approval, for the treatment of R/R Diffuse Large B-Cell Lymphoma (DLBCL).

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References:

[1] U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma. Retrieved February 27, 2024 from https://www.globenewswire.com/news-release/2024/02/27/2835606/0/en/U-S-FDA-Accepts-for-Priority-Review-the-Supplemental-Biologics-License-Application-for-Epcoritamab-EPKINLY-for-Difficult-to-Treat-Relapsed-or-Refractory-Follicular-Lymphoma.html

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