The FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp. This subcutaneously administered T-cell engaging bispecific antibody is being evaluated for its efficacy in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of therapy.
The Importance of Priority Review
Priority Review is granted by the FDA to investigational therapies that have the potential to significantly improve the safety or effectiveness of treating serious conditions compared to standard applications. This designation shortens the review period to six months, as opposed to the standard 10 months. If approved, epcoritamab-bysp (EPKINLY®) could become the first subcutaneous bispecific antibody approved for adults with R/R FL after two prior lines of therapy, presenting a new option for patients facing this challenging condition.
[VIDEO EXCLUSIVE] Evaluating Epcoritamab’s Impact: Insights from the Phase 1/2 EPCORE™ NHL-1 Clinical Trial
Clinical Data Supporting the Application
The sBLA is supported by data from the Phase 1/2 EPCORE™ NHL-1 clinical trial, which demonstrated promising treatment responses in patients with R/R FL after multiple lines of therapy. The trial’s results, including overall and complete response rates, were presented at the Annual Meeting and Exposition of the American Society of Hematology (ASH) in December 2023. Additionally, the trial’s optimization cohort explored alternative dosing regimens to minimize the risk of cytokine release syndrome (CRS), a potential side effect of the therapy.
Addressing Unmet Needs
“Despite new treatment options, follicular lymphoma remains incurable and difficult to treat. Unfortunately, relapse is common and additional lines of treatment are needed,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “Together with our partner Genmab, we are committed to further advancing epcoritamab as a core lymphoma therapy.”
About Follicular Lymphoma (FL)
FL is a form of non-Hodgkin’s lymphoma characterized by its indolent nature, originating from B-lymphocytes. While it is considered incurable with conventional therapy, new treatments like epcoritamab offer hope for patients facing relapsed or refractory disease after multiple lines of therapy.
About Epcoritamab and Ongoing Research
Epcoritamab, developed using Genmab’s DuoBody® technology, is designed to target CD20+ cells by simultaneously binding to CD3 on T cells and CD20 on B cells, leading to T-cell-mediated killing of cancerous cells. The drug has already received regulatory approval for certain types of diffuse large B-cell lymphoma (DLBCL) under the brand name EPKINLY® in the United States and TEPKINLY® in the European Union.
Continuing research efforts include evaluating epcoritamab’s efficacy as a monotherapy and in combination therapies across different lines of therapy in various hematologic malignancies. Phase 3 trials are underway to assess epcoritamab in combination with other agents for patients with DLBCL and FL.
Conclusion
The FDA’s Priority Review of the sBLA for epcoritamab represents a significant advancement in the treatment landscape for R/R FL. If approved, epcoritamab-bysp could offer a valuable therapeutic option for patients who have exhausted other treatment avenues. The collaboration between AbbVie and Genmab reflects a shared commitment to advancing innovative therapies for patients with hematologic malignancies, providing hope for individuals and families affected by these challenging diseases.
Reference Links:
U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma: https://ir.genmab.com/news-releases/news-release-details/us-fda-accepts-priority-review-supplemental-biologics-license
U.S. Food and Drug Administration (FDA) Grants Priority Review of Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma (FL): https://news.abbvie.com/2024-02-27-U-S-Food-and-Drug-Administration-FDA-Grants-Priority-Review-of-Epcoritamab-EPKINLY-R-for-Difficult-to-Treat-Relapsed-or-Refractory-Follicular-Lymphoma-FL
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