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Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

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  • The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos. 
  • The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates & safety in r/r FL or r/r DLBCL adults 
  • Regeneron is assessing odronextamab alone & in combinations as earlier lines of therapies for lymphomas, incl. the registrational ELM-1 & ELM-2 trial, P-III (OLYMPIA) study for B-NHLs and early-stage studies with CT-free combinations 

Ref: Regeneron| Image: Regeneron| Press Release

Related News:- Merck’s Winrevair (Sotatercept) Gains the CHMP’s Positive Opinion to Treat Pulmonary Arterial Hypertension (PAH)

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