AbbVie’s Epkinly (epcoritamab-bysp) Receives the US FDA’s Accelerated Approval to Treat R/R Follicular Lymphoma

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The accelerated approval was based on P-I/II (EPCORE NHL-1) study of Epkinly (SC) in adults (n=127) with r/r or progressive CD20+ mature B-NHL incl. FL post ≥2L of systemic therapy. Full approval depends on confirmatory studies
Trial depicted an ORR of 82%, CR rate of 60% & PR rate of 22% with >50% of responders sustaining their responses to the treatment at 14.8mos. of median follow-up
Epcoritamab, an IgG1-bispecific Ab developed using Genmab’s DuoBody technology, activates T-cell-induced CD20+ cell destruction by binding with CD3 & CD20 on T & B cells, respectively. Additionally, both companies will co-develop & commercialize it in the US & Japan, whereas AbbVie will commercialize it in ROW solely

Ref: AbbVie | Image: AbbVie

Related News:- AbbVie’s Tepkinly (epcoritamab) Receives EMA’s CHMP Positive Opinion for the Treatment of Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma

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