Drug Type Bispecific T-cell Engager (BiTE) |
Synonyms Anti-CD3 anti-CD20 bispecific antibody, Anti-CD3 anti-CD20 bispecific antibody(Genmab A/S), epcoritamab-bysp + [7] |
Target |
Action inhibitors, stimulants |
Mechanism CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (19 May 2023), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States), Breakthrough Therapy (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Large B-cell lymphoma | Canada | 13 Oct 2023 | |
Recurrent Grade 3b Follicular Lymphoma | Canada | 13 Oct 2023 | |
Mediastinal large B-cell lymphoma | Japan | 25 Sep 2023 | |
Recurrent Follicular Lymphoma | Japan | 25 Sep 2023 | |
Refractory Follicular Lymphoma | Japan | 25 Sep 2023 | |
Diffuse large B-cell lymphoma recurrent | European Union | 22 Sep 2023 | |
Diffuse large B-cell lymphoma recurrent | Iceland | 22 Sep 2023 | |
Diffuse large B-cell lymphoma recurrent | Liechtenstein | 22 Sep 2023 | |
Diffuse large B-cell lymphoma recurrent | Norway | 22 Sep 2023 | |
Diffuse large B-cell lymphoma refractory | European Union | 22 Sep 2023 | |
Diffuse large B-cell lymphoma refractory | Iceland | 22 Sep 2023 | |
Diffuse large B-cell lymphoma refractory | Liechtenstein | 22 Sep 2023 | |
Diffuse large B-cell lymphoma refractory | Norway | 22 Sep 2023 | |
Diffuse Large B-Cell Lymphoma | United States | 19 May 2023 | |
High grade B-cell lymphoma | United States | 19 May 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Refractory Grade 3a Follicular Lymphoma | Phase 3 | United States | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | China | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Japan | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Australia | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Belgium | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Bulgaria | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Croatia | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Czechia | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | Denmark | 05 Feb 2024 | |
Refractory Grade 3a Follicular Lymphoma | Phase 3 | France | 05 Feb 2024 |
NCT04623541 (ASH2024) Manual | Phase 1/2 | 40 | (expansion cohort (EXP)) | wuwacotsws(sjvgppzzfq) = oryirumfjp zhmpjvzhqk (rmkcanhqim ) View more | Positive | 09 Dec 2024 | |
(TP53 aberrations) | wuwacotsws(sjvgppzzfq) = ozwmkotmga zhmpjvzhqk (rmkcanhqim ) View more | ||||||
Phase 2 | Large B-cell lymphoma First line | 44 | Epcoritamab SC (arm A) | sinfqxtnlg(tuzdmboyra) = qcierhkqqw gxqcjyfbtn (zccuvuegke ) View more | Positive | 09 Dec 2024 | |
Not Applicable | - | Epcoritamab monotherapy | kayyriajbv(ybqgehrsbe) = 51% (32% G1, 16% G2, 3% G3) kshroxznct (nwakdwhdmc ) View more | - | 09 Dec 2024 | ||
Not Applicable | - | - | Epcoritamab + R-CHOP | bbhsrmomgn(hiqzuidoyj) = 60% uxjmvrohvm (jkrvjghyms ) View more | - | 08 Dec 2024 | |
Not Applicable | - | cvouthypnl(fnleozewke) = grade 3-4 treatment-emergent adverse events (TEAEs) were CRS (10%) rfqpabuxzp (ukzyllsyea ) View more | - | 08 Dec 2024 | |||
Not Applicable | - | wrfrbyusdd(ttatqnpqid) = svoqjrhtmn wzfgqbhaza (qztxzxcrdo, 42.1 - 75.2) View more | - | 08 Dec 2024 | |||
wrfrbyusdd(ttatqnpqid) = aiaqzabznc wzfgqbhaza (qztxzxcrdo, 52.6 - 72.1) View more | |||||||
Not Applicable | - | Epcoritamab 48 mg + R-mini-CHOP | nqmbpakvyw(ilsflzwnqz) = All CRS events were low grade (25% grade 1, 29% grade 2), and most events were observed after the first full dose of epcoritamab. All CRS events resolved, and 1 pt (4%) discontinued epcoritamab due to CRS. No ICANS or clinical tumor lysis syndrome events were reported. sehxdizvqa (lwetondxjr ) View more | - | 08 Dec 2024 | ||
Phase 1/2 | Follicular Lymphoma First line | 25 | lokhhvzcqz(iwmffbegtm) = qtnezbiubk xfhjfxnmzi (wniojtkxxd ) View more | Positive | 07 Dec 2024 | ||
Phase 1/2 | Follicular Lymphoma Second line | Last line | Third line | 111 | zdvrcvbcpt(spurbrgjyp) = xaoqzthpwb nalsphyqzp (mvplmdurih ) View more | Positive | 07 Dec 2024 | ||
Phase 1/2 | - | zljnzqpsqy(xfydwbwoig) = wqiipwwyqa rjcydquxyy (cyxcwslnfs ) View more | - | 07 Dec 2024 | |||
Glofitamab | zljnzqpsqy(xfydwbwoig) = oeylknsnqs rjcydquxyy (cyxcwslnfs ) View more |