Tepkinly (epcoritamab)
- Region
- 🇪🇺 EU
- Active substance
- epcoritamab
- Company
- AbbVie Deutschland GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Lymphoma, Large B-Cell, Diffuse
- CHMP opinion
- Thu 20 Jul 2023
- EU approval
- Fri 22 Sep 2023
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005985
- ATC
- L01FX27
- Official record
- www.ema.europa.eu
Indication
Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Regulatory milestones
No milestones recorded in the last year.
Follow Tepkinly
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.