AbbVie and Genmab's Epkinly (epcoritamab-bysp) Receives the US FDA’s Approval for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Shots:
- The US FDA has approved Epkinly for adult patients with r/r DLBCL. The therapy is being co-developed by AbbVie & Genmab
- The approval was based on the P-I/II trial (EPCORE NHL-1) evaluating epcoritamab (SC) in patients with r/r B-cell lymphoma. The results showed ORR (61%) with CR (38%) and PR (23%), and m-DoR was 15.6mos. after a median follow-up of 9.8mos., 82% of patients had disease refractory to the last therapy & 29% were refractory to CAR T-cell therapy. The safety profile was consistent with prior studies
- Epkinly, an IgG1-bispecific Ab developed using Genmab's DuoBody technology. Both companies will share commercial responsibilities in the US & Japan while AbbVie responsible for further global commercialization
Ref: AbbVie | Image: AbbVie
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