Epcoritamab
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | DRUG-EPCORITAMAB |
|---|---|
| Type | Médicament |
| Alias | EpkinlyTépkineЕпкоритамаб |
| État | reviewed 2026-04-29 | pending_clinical_signoff |
| Maladies | Aucune déclaration |
| Sources | SRC-ESMO-DLBCL-2024 SRC-ESMO-FL-2024 SRC-NCCN-BCELL-2025 |
Faits sur les drogues
| Catégorie | CD20 × CD3 enclencheur bispécifique de cellules T (IgG1, plateforme DuoBody humanisée; administration SC) |
|---|---|
| Mécanisme | 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. |
| Dose typique | 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 enregistrée | Faux |
| NSZU remboursé | Faux |
| Ukraine vérifiée pour la dernière fois | 2026-04-29 |
Avertissements
- Syndrome de libération de cytokine (SRC) — ~50% de toute catégorie, ~3% de grade ≥3 dans la LNH-1 EPCORE
- Toxicité neurologique / ICANS (~6%)
- Infections graves — Grade ≥3 ~15-20%
Notes
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.
Utilisé par
Protocole thérapeutique
REGIMEN-EPCORITAMAB-MONO-DLBCL-3L- Epcoritamab SC en monothérapie pour la DLBCL ≥3L (EPCORE NHL-1)REGIMEN-EPCORITAMAB-STEP-UP-DOSING- Epcoritamab cycle-1 sous-régime posologique progressif (CRS mesures d ' atténuation)