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Regeneron’s Ordspono (Odronextamab) Receives the EC’s Approval to Treat R/R Follicular Lymphoma and Diffuse Large B-cell Lymphoma 

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  • The EC has approved Ordspono for treating r/r FL or r/r DLBCL in patients who have progressed after ≥2L of systemic therapy 
  • Approval was supported by Ordspono’s P-I (ELM-1; n=60) trial in patients with CD20+ B-cell malignancies, incl. those who progressed post CAR-T therapy & P-II (ELM-2; n=128) trial for 5 B-cell lymphoma subtypes such as DLBCL, FL, mantle cell lymphoma, marginal zone lymphoma 
  • R/R FL patients (ELM-2) had an ORR of 80% & CR in 73% (mDoR: 25mos.); r/r DLBCL patients naïve to CAR T therapy (ELM-2) had an ORR of 52% & CR in 31% (mDoR: 18mos.); r/r DLBCL patients who progressed post CAR-T therapy (ELM-1) had an ORR of 48% & CR in 32% (mDoR: 15mos. 

Ref: Regeneron  | Image: Regeneron| Press Release

Related News:- SIFI and Avanzanite Bioscience’s Akantior (Polihexanide) Gains the EC’s Approval to Treat Acanthamoeba Keratitis (AK) 

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