Talquetamab
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| ID | DRUG-TALQUETAMAB |
|---|---|
| Tipo | Fármaco |
| Alegais | TalveyТалквотамаб |
| Estado | reviewed 2026-04-29 | pending_clinical_signoff |
| Doenças | Nenhuma declaração |
| Fontes | SRC-ESMO-MM-2023 SRC-NCCN-MM-2025 |
Fatos sobre as drogas
| Classe | GPRC5D × CD3 engajador biespecífico de células T (IgG4) humanizado |
|---|---|
| Mecanismo | 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). |
| Dose típica | 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). |
| Ucrânia registada | Falso |
| NSZU reembolsado | Falso |
| Ucrânia verificada pela última vez | 2026-04-29 |
Avisos
- Síndrome de libertação de citocina (SCR) — ~75% de qualquer grau, ~2% Grau ≥3 em Monumental-1
- Toxicidade neurológica / ICANS (~10%)
- Toxicidade oral (disgeusia, disfagia, boca seca) — ~75%, efeito distintivo de classe
- Toxicidade da pele/unha (erupção cutânea, exfoliação palmoplantar, distrofia ungueal) — ~70%
- Perda de peso (>5% em ~40%; secundária à toxicidade do paladar/oral)
Notas
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.
Usado por
Esquema terapêutico
REGIMEN-TALQUETAMAB-MONO-MM- Talquetamab GPRC5D × CD3 em monoterapia biespecífica — SC (próxima fase; programa QW ou Q2W)REGIMEN-TALQUETAMAB-QW-Q2W-MM- Talquetamab GPRC5D × CD3 biespecífico — Calendário de manutenção Q2W (Monumental-1 coorte B)REGIMEN-TALQUETAMAB-STEP-UP-DOSING-MM- Talquetamab GPRC5D × CD3 biespecífico — esquema posológico acelerado do doente