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
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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.
