FDA grants priority review to epcoritamab for advanced lymphoma
Click Here to Manage Email Alerts
The FDA granted priority review to epcoritamab for treatment of certain patients with advanced lymphoma, according to the agent’s manufacturer.
The designation applies to use of the agent by individuals with relapsed or refractory large B-cell lymphoma who received at least two lines of systemic therapy.
Epcoritamab (DuoBody-CD3xCD20;Genmab, AbbVie) is an investigational IgG1-bispecific antibody created with Genmab’s proprietary DuoBody technology. The agent is designed to bind simultaneously to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20-positive cells, according to a Genmab-issued press release.
The biologics license application is based on results from phase 2 EPCORE NHL-1 trial. Researchers evaluated subcutaneous epcoritamab for patients with relapsed, progressive or refractory CD20-positive mature B-cell non-Hodgkin lymphoma, including large B-cell lymphoma and diffuse large B-cell lymphoma.
“We are pleased that the [application] for epcoritamab has been accepted for priority review by the FDA, accelerating the pathway for approval and bringing us one step closer to potentially delivering a novel treatment option to [patients with relapsed or refractory large B-cell lymphoma] who are in need of additional treatment options,” Jan van de Winkel, PhD, CEO of Genmab, said in the release. “Together with our partner, AbbVie, we recognize the unmet need for safe, effective and accessible treatments for patients with B-cell malignancies and we believe that epcoritamab has the potential to become a core therapy in this patient population.”
The FDA is expected to make a decision on the application by May 21, 2023.
Read more about
Click Here to Manage Email Alerts