Amivantamab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-AMIVANTAMAB |
|---|---|
| Тип | Препарат |
| Синоніми | JNJ-61186372Rybrevantamivantamab-vmjwАмівантамаб |
| Статус | переглянуто 2026-04-27 | очікує клінічного підпису |
| Хвороби | DIS-NSCLC |
| Джерела | SRC-ESMO-NSCLC-METASTATIC-2024 SRC-NCCN-NSCLC-2025 |
Дані про препарат
| Клас | EGFR x MET bispecific monoclonal antibody |
|---|---|
| Механізм дії | Fully human bispecific IgG1 antibody simultaneously binding extracellular domains of EGFR (epidermal growth factor receptor) and MET (hepatocyte growth factor receptor / c-Met). The dual engagement triggers (1) ligand-blocking inhibition of both receptors, (2) downregulation / internalization of EGFR-MET heterodimers, (3) Fc-mediated effector function (ADCC, trogocytosis, ADCP) via low-fucose engineered Fc. Active against EGFR exon-20 insertion mutations (which are insensitive to classical EGFR-TKIs) and against secondary MET-amplification- mediated resistance to osimertinib. Pivotal evidence: CHRYSALIS (EGFR exon 20 ins NSCLC post-platinum: ORR ~40%, FDA accelerated 2021 — first targeted therapy for ex20ins); MARIPOSA (amivantamab + lazertinib vs osimertinib 1L EGFR ex19del/L858R NSCLC: mPFS 23.7 vs 16.6 mo HR 0.70, FDA Aug 2024); MARIPOSA-2 (amivantamab + chemo ± lazertinib vs chemo p... |
| Типове дозування | Weight-based: <80 kg = 1050 mg IV; ≥80 kg = 1400 mg IV. Cycle 1: loading dose split over Day 1 (350 mg + remainder) and Day 2 (full dose); then weekly Days 8, 15, 22 of cycle 1 (3-week cycle). Cycles 2 onward: every 2 weeks. SC formulation (amivantamab-vmjw SC, with hyaluronidase, approved Mar 2024 on PALOMA-3): same fixed mg-by- weight, administered SC over ~5 minutes — substantially reduced infusion-related reaction rate (~13% vs ~65% IV) and ~5-fold shorter chair time. Premedication mandatory for IV (especially cycle-1 day-1): IV corticosteroid (dexamethasone 10-20 mg or methylprednisolone 40 mg), antihistamine (diphenhydramine 25-50 mg), antipyretic (acetaminophen 650-1000 mg). VTE prop... |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-27 |
Нотатки
SC formulation strongly preferred from cycle-2 onward where available — substantially lower IRR rate (PALOMA-3 ~13% vs ~65% IV) and shorter administration time. Cycle-1 day-1 IV infusion split (350 mg → wait → remainder) reduces IRR severity. VTE prophylaxis (prophylactic-dose LMWH or DOAC for first 4 months) is mandated by the MARIPOSA / MARIPOSA-2 protocols when combined with lazertinib — VTE risk is substantially elevated vs ami or laz monotherapy. Premedication for IV (steroid + antihistamine + antipyretic) is non-negotiable. Aggressive EGFR-class skin care (clindamycin gel, oral doxycycline 100 mg BID prophylaxis, emollients, sun protection); paronychia: chlorhexidine soaks + high-potency topical steroid + careful nail care. Baseline workup: LFTs, albumin, CBC, ECG, pregnancy test, CT chest (ILD baseline). Monitor LFTs / CBC / albumin q2 wk first 8 wk then monthly; CT chest at any new respiratory symptoms. UA access via EAP / self-pay only.
Де використовується
Indications
IND-NSCLC-EGFR-1L-AMI-LAZ- IND-NSCLC-EGFR-1L-AMI-LAZ
Regimens
REG-AMI-LAZ-NSCLC- Amivantamab + Lazertinib (MARIPOSA) — 1L EGFR-mut NSCLCREG-AMIVANTAMAB-CHEMO- Amivantamab + Carboplatin + Pemetrexed (NSCLC EGFR-mut post-osimertinib, MARIPOSA-2)REG-AMIVANTAMAB-LAZERTINIB-NSCLC-2L- Amivantamab + Lazertinib (MARIPOSA-2) — 2L EGFR-mut NSCLC post-osimertinibREG-AMIVANTAMAB-MONO-NSCLC-EX20INS- Amivantamab monotherapy (CHRYSALIS) — 2L EGFR Exon 20 insertion NSCLC