Epcoritamab: Tepkinly

Marketing authorisation number: 69481, date marketing authorisation granted: 15/02/2024

We publish synopses from Clinical Study Reports (CSR) to supplement the public information. This provides patients and healthcare providers with the results of our clinical trials and the evidence used to authorise Tepkinly.

Here you can find the CSR synopses after Tepkinly was granted marketing authorisation in Switzerland.

GCT3013-01

Study Indication: Diffuse large B-cell Lymphoma (DLBCL)
Phase: Phase 1/2
Study Name:
A Phase 1/2, Open-Label, Dose Escalation Trial of Epcoritamab in Patients with Relapsed, Progressive or Refractory B-cell Lymphoma.
EudraCT-Number: 2017-001748-36


GTC3013-04

Study Indication: Diffuse large B-cell Lymphoma (DLBCL)
Phase: Phase 1/2
Study Name:
Safety and Preliminary Efficacy of Epcoritamab in Japanese Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
(B-NHL) - A Phase 1/2 Open-Label, Dose-Escalation trial with Expansion Cohorts.JapicCTI-Nummer: Japic-CTI-20540