- Genmab has submitted a Biologics License Application (BLA) for epcoritamab to the US Food and Drug Administration (FDA).
- The European Medicines Agency (EMA) has validated AbbVie’s Marketing Authorization Application (MAA) for epcoritamab
- The filings are supported by the open-label, multi-center, Phase 2 EPCORE™ NHL-1 study evaluating the safety and preliminary efficacy of epcoritamab in adult patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL)
Genmab A/S GMAB announced today that the company has filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA). 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. In addition, Genmab announced that AbbVie ABBV has submitted a Marketing Authorization Application (MAA) for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, which has been validated by the European Medicines Agency (EMA).
The regulatory filings are supported from before announced Results from the LBCL cohort of the pivotal, open-label, multi-center, Phase 2 EPCORE™ NHL-1 clinical trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including DLBCL. These findings were presented in a late-breaking oral presentation at the Presidential Symposium at the 27thth Annual Meeting of the European Hematology Association (EHA2022) on June 11, 2022 in Vienna, Austria.
“Even with existing therapies to treat these lymphomas, there is a significant unmet medical need for alternative and accessible treatment options for patients who are intolerant to current treatments or whose…
