Talquetamab
Deterministische Ansicht der Quelle YAML Entität. Klinische Autorität bleibt mit den zitierten Quell-IDs und Rezensenten Sign-off Zustand.
| ID | DRUG-TALQUETAMAB |
|---|---|
| Art | Arzneimittel |
| Aliase | TalveyТалквотамаб |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Erkrankungen | None declared |
| Quellen | SRC-ESMO-MM-2023 SRC-NCCN-MM-2025 |
Drug Facts
| Klasse | GPRC5D × CD3 bispezifischer T-Zell-Embler (humanisiertes IgG4) |
|---|---|
| Verfahren | Humanized IgG4 bispecific antibody binding GPRC5D (G-protein- coupled receptor family C group 5 member D, highly expressed on malignant plasma cells with restricted normal-tissue expression to keratinized epithelia + hair follicles + tongue) on one arm and CD3 on T-cells. Redirects T-cell cytotoxicity to GPRC5D+ myeloma. First-in-class non-BCMA bispecific — orthogonal target for patients progressing on BCMA-directed therapy. On-target off-tumor toxicity profile reflects normal GPRC5D expression (taste/skin/nail toxicities). |
| Typische Dosierung | Two approved schedules: weekly 0.4 mg/kg SC (step-up: 0.01 → 0.06 → 0.4 mg/kg SC q3-4d) or biweekly 0.8 mg/kg SC (step-up: 0.01 → 0.06 → 0.3 → 0.8 mg/kg SC). Hospitalization required for step-up doses. Maintenance until progression. Biweekly schedule preferred for prolonged therapy (improved tolerability; reduced infection surveillance burden). |
| Ukraine registriert | Falsch |
| NSZU erstattet | Falsch |
| Ukraine zuletzt überprüft | 2026-04-29 |
Warnungen
- Cytokin-Freisetzungssyndrom (CRS) — ~75 % aller Grade, ~2% Grad ≥3 in MonumenTAL-1
- Neurologische Toxizität / ICANS (~10%)
- Orale Toxizität (Dysgeusie, Dysphagie, Mundtrockenheit) — ~75 %, ausgeprägte Klasse-Effekt
- Haut-/Nierentoxizität (Ausschlag, Palmoplantarausschlag, Nageldystrophie) — ~70%
- Gewichtsverlust (>5% in ~40%; sekundäre Geschmacks-/orale Toxizität)
Anmerkungen
MonumenTAL-1 (Chari 2022, NEJM): triple-class refractory MM after ≥4 prior lines — ORR ~73% (weekly cohort), ~74% (biweekly cohort), mDOR ~9-13 mo. FDA accelerated approval Aug 2023; EMA Aug 2023. Distinctive toxicity profile: taste/oral/nail/skin AEs reflect GPRC5D expression in keratinized tissues — manageable but quality- of-life-impacting; nutrition + dental support critical. Lower infection burden vs BCMA bispecifics (different antigen niche; intact humoral immunity). Useful for sequencing post-BCMA failure (orthogonal target). Bibliographic record SRC-MONUMENTAL-1-CHARI-2022 is available; clinical claim linkage requires dual clinical sign-off.
Verwendet von
Therapieschema
REGIMEN-TALQUETAMAB-MONO-MM- Talquetamab GPRC5D × CD3 bispezifische Monotherapie — SC (nach dem Step-up; QW- oder Q2W-Schema)REGIMEN-TALQUETAMAB-QW-Q2W-MM- Talquetamab GPRC5D × CD3 bispezifisch — Q2W-Wartungsplan (MonumenTAL-1 Kohorte B)REGIMEN-TALQUETAMAB-STEP-UP-DOSING-MM- Talquetamab GPRC5D × CD3 bispezifisch — stationäres Step-up-Dosierungsprogramm