FDA accepts for priority review BLA for epcoritamab for the treatment of relapsed/refractory large B-cell lymphoma
Genmab A/S announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for subcutaneous epcoritamab (DuoBody-CD3xCD20), an investigational bispecific antibody, for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of 21 May, 2023.
The BLA submission is based on safety and preliminary efficacy data from the LBCL cohort of the pivotal EPCORE NHL-1 open-label, multi-center phase II clinical trial evaluating epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL). These results were presented in a late-breaking oral presentation as a part of the Presidential Symposium at the 27th Annual Meeting of the European Hematology Association (EHA2022), in Vienna, Austria.
In October 2022, the European Medicines Agency validated for review a Marketing Authorization Application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory DLBCL– a major subtype of LBCL – after two or more lines of systemic therapy.
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