AbbVie’s Tepkinly (epcoritamab) Receives EMA’s CHMP Positive Opinion for the Treatment of Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending conditional marketing authorization for epcoritamab as monotx. for adult patients with r/r DLBCL after two or more lines of systemic therapy. The EC’s decision is expected in 2023
- The opinion was based on the P-I/II open-label trial (EPCORE NHL-1) evaluating epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL incl. DLBCL. The therapy is being co-developed by AbbVie & Genmab
- The 1EPs of the study was ORR (63.1%) as assessed by IRC. If epcoritamab is approved, it will become 1st SC bispecific Ab conditionally approved as a monotx. for r/r DLBCL & will be marketed under the brand name Tepkinly in all EU member states, Liechtenstein, Norway, and Iceland
Ref: AbbVie | Image: AbbVie
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
