Regeneron Reports EMA Acceptance of MAA for Odronextamab to Treat Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
- The EMA has accepted the MAA for review of odronextamab (CD20xCD3 bispecific Ab) for adult patients with r/r FL or r/r DLBCL who have progressed after 2 prior systemic therapies. The MAA was based on the P-I study (ELM-1) and P-II trial (ELM-2) evaluating odronextamab in FL and DLBCL
- Both studies' results presented at ASH for r/r FL showed ORR (82%) in patients with grades 1 to 3a disease, CR (75%), median duration of complete response (mDOCR) was 20.5mos., m-PFS (20mos.), m-OS (not reached)
- Among CAR-T naïve & post-CAR-T patients showed ORR (49% & 48%), CR (31% & 32%), mDOCR was 18mos. & not reached, respectively for r/r DLBCL. The company continues to advance odronextamab in the P-III development program for earlier lines of therapy & additional B-NHLs
Ref: Globenewswire | Image: Regeneron
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