AbbVie Receives EC’s Conditional Marketing for Tepkinly (Epcoritamab) to R/R Follicular Lymphoma (FL)
Shots:
- The EC has granted conditional MAA to Tepkinly as a monotx. in 2L+ r/r follicular lymphoma (FL) patients (n=128) based on P-I/II (EPCORE NHL-1) trial
- The results from EPCORE NHL-1 study assessing Tepkinly (SC) in adults with r/r or progressive CD20+ mature B-NHL incl. FL post ≥2L of systemic therapy; safety profile was consistent with the pivotal EPCORE NHL-1 DLBCL cohort
- Another arm assessing a 3-step-up dosing (SUD) schedule (n=86) showed CRS incidence (Gr1: 40%; Gr2: 9%) with no Gr3 & above events. Data published in the Lancet Haematology showed an ORR (83%) & CR rate (63%). After a median follow-up period of 16.2 mos., the mDOR is 21.4 mos. (13.7 mos. to NA)
Ref: AbbVie | Image: AbbVie
Related News:- AbbVie’s Tepkinly (Epcoritamab) Gains the CHMP’s Positive Opinion to Treat R/R Follicular Lymphoma
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