Logo

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

Share this
AbbVie

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

Shots:

  • The acclerated 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 (Genmab was the sBLA holder). 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

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions