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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)
Shots:
- 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
Related News:- Regeneron Showcases Updated P-I/II (LINKER-MM1) Study Data of Linvoseltamab for Treating R/R Multiple Myeloma at EHA 2024
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.