AbbVie and Genmab Receive EC’s Conditional Marketing for Tepkinly (epcoritamab) to Treat Relapsed or Refractory Diffuse Large B-cell Lymphoma
Shots:
- The EC has granted conditional marketing authorization for Tepkinly as a monotx. for the treatment of adult patients with r/r DLBCL after two or more lines of systemic therapy
- The approval was based on the results from the P-I/II trial (EPCORE NHL-1) evaluating Tepkinly in patients with r/r LBCL incl. subtype DLBCL. The results showed ORR (62%) and a CR rate (39%), m-DoR was 15.5mos. & also demonstrated a manageable safety profile across the LBCL patient cohort incl. the DLBCL patient population
- Tepkinly, an IgG1-bispecific Ab that has been developed using Genmab's DuoBody technology. Epcoritamab was approved in the US under the brand name Epkinly in May 2023 for r/r DLBCL
Ref: PR Newswire | Image: AbbVie
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