Epcoritamab
Deterministische Ansicht der Quelle YAML Entität. Klinische Autorität bleibt mit den zitierten Quell-IDs und Rezensenten Sign-off Zustand.
| ID | DRUG-EPCORITAMAB |
|---|---|
| Art | Arzneimittel |
| Aliase | Sehr schönTepkinischЕпкоритамаб |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Erkrankungen | None declared |
| Quellen | SRC-ESMO-DLBCL-2024 SRC-ESMO-FL-2024 SRC-NCCN-BCELL-2025 |
Drug Facts
| Klasse | CD20 × CD3 bispezifischer T-Zell-Embler (humanisierte IgG1, DuoBody-Plattform; SC-Administration) |
|---|---|
| Verfahren | Humanized IgG1 bispecific antibody (Genmab DuoBody platform) binding CD20 on B-cells and CD3 on T-cells, redirecting polyclonal T-cell cytotoxicity to CD20+ malignant B-cells. Subcutaneous administration with step-up dosing schedule mitigates first-cycle CRS. First-in-class SC CD20×CD3 bispecific (vs IV mosunetuzumab/glofitamab) — improves ambulatory administration profile. |
| Typische Dosierung | Step-up dosing required (CRS mitigation): 0.16 mg SC day 1 (cycle 1), 0.8 mg SC day 8 (cycle 1), 48 mg SC day 15 (cycle 1) and day 22. Cycles 2-3 (28-day cycles): 48 mg SC weekly. Cycles 4-9: 48 mg SC every 2 weeks. Cycles 10+: 48 mg SC every 4 weeks until progression / unacceptable toxicity. Hospitalization required for first 48 mg dose (cycle 1 day 15, 24h observation). |
| Ukraine registriert | Falsch |
| NSZU erstattet | Falsch |
| Ukraine zuletzt überprüft | 2026-04-29 |
Warnungen
- Cytokin-Freisetzungssyndrom (CRS) — ~50% jeder Grad, ~3% Grad ≥3 in EPCORE NHL-1
- Neurologische Toxizität / ICANS (~6%)
- Schwere Infektionen — Grad ≥ 3 ~ 15-20%
Anmerkungen
EPCORE NHL-1 (Thieblemont 2023, JCO): r/r DLBCL after ≥2 prior lines (median 3; ~38% post-CAR-T) — ORR 63%, CR 39%, mDOR ~12 mo. Subset r/r FL ≥2L (Linton 2023, Lancet Haematol): ORR 82%, CR 63%. FDA accelerated approval May 2023 (DLBCL), Jun 2024 (FL). Distinct from CAR-T: off-the-shelf, no lymphodepletion, ambulatory after cycle 1 day 15. Useful in patients ineligible for CAR-T (frailty, comorbidity, manufacturing delay) or post-CAR-T progression. Lower depth/duration of response vs CAR-T in DLBCL but better tolerability. Hospital observation required for first 48 mg dose (cycle 1 day 15). Mandatory PJP + HSV prophylaxis; IVIG for IgG <400. NOTE: Bibliographic record SRC-EPCORE-NHL-1-THIEBLEMONT-2023 is available; clinical claim linkage requires dual clinical sign-off.
Verwendet von
Therapieschema
REGIMEN-EPCORITAMAB-MONO-DLBCL-3L- Epcoritamab SC Monotherapie für r/r DLBCL ≥3L (EPCORE NHL-1)REGIMEN-EPCORITAMAB-STEP-UP-DOSING- Epcoritamab Zyklus-1 Schritt-up-Dosierung Sub-Regimen (CRS-Abschwächung)