Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise…. Sold as Epkinly. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Epcoritamab-Bysp (sold as Epkinly), first approved May 19, 2023, with 3 new uses approved and 0 published complete response letters.
First approved: May 19, 2023
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $76.7M
Orphan exclusivity until: Jun 26, 2031
First approved in the EU: Sep 22, 2023
First approved in Japan: Sep 25, 2023
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 4 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
EpkinlyDrugs with a new dosage indicated for the treatment of relapsed or refractory follicular lymphoma (Grade 1 to Grade 3 A). · Genmab K.K. · Feb 20, 2025
Epkinly, new ingredientDrugs with a new active ingredient indicated for the treatment of relapsed or refractory large B-cell lymphoma (diffuse large B-cell lymphoma, high- grade… · Genmab K.K. · Sep 25, 2023
Clinical Trials
12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
