AbbVie’s Tepkinly (Epcoritamab) Gains the CHMP’s Positive Opinion to Treat R/R Follicular Lymphoma

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The CHMP has granted positive opinion to Tepkinly (SC) monotx. in r/r follicular lymphoma (FL) patients treated with ≥2L of therapy, with the decision anticipated during H2’24
The opinion was based on ORR results of P-I/II (EPCORE NHL-1) study assessing Tepkinly (SC) in adults (n=128) 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 in 86 patients to reduce CRS incidence & severity showed CRS incidence of 49% (42/86; 9% were grade 2) without grade 3 or higher events. Data was published in the Lancet Haematology

Ref: AbbVie | Image: AbbVie

Related News:- AbbVie and Genmab Receive EC’s Conditional Marketing for Tepkinly (epcoritamab) to Treat Relapsed or Refractory Diffuse Large B-cell Lymphoma

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