www.fdanews.com/articles/210031-genmab-and-abbvie-submit-applications-for-lymphoma-drug-candidate
Genmab and AbbVie Submit Applications for Lymphoma Drug Candidate
November 2, 2022
Genmab has submitted a Biologics License Application (BLA) to the FDA for epcoritamab for treatment of fast-growing forms of non-Hodgkin’s lymphoma.
An investigational antibody designed to simultaneously bind to and kill cancer cells, epcoritamab is being co-developed by AbbVie and Genmab under a collaboration deal inked in 2020.
The FDA application seeks approval for the treatment of adult patients with relapsed/drug-resistant large B-cell lymphoma after two or more lines of systemic therapy.
The European Medicines Agency (EMA) has accepted an application by AbbVie for epcoritamab for treating patients with relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.