28 October 2022 - EMA validates AbbVie's marketing authorisation application; Genmab submits biologics license application to US FDA.
AbbVie today announced that the EMA has validated a marketing authorisation application for epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Additionally, Genmab has submitted a biologics license application to the US FDA for epcoritamab for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy.