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Amivantamab

A two-armed antibody that blocks EGFR and its escape partner MET, now first-line for EGFR-mutant lung cancer with lazertinib.

Approved for EGFR exon 20 insertion NSCLC (2021, with chemotherapy 2024, PAPILLON), first-line common EGFR mutations with lazertinib (MARIPOSA, 2024; OS benefit shown 2025), and post-osimertinib with chemotherapy (MARIPOSA-2). Subcutaneous formulation (2025) reduces infusion reactions.

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Amivantamab anti-MET Fab arm bound to MET (PDB 6WVZ), backbone trace
RCSB PDB
Mechanism, step by step
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1.Bispecific antibody binds EGFR and MET on the tumour cell

Modality
Bispecific antibody (EGFR×MET)
Mechanism
Low-fucose bispecific IgG1 blocking EGFR and MET with enhanced ADCC/trogocytosis.
Brand / code
Rybrevant
Dosing & schedule
Route
IV infusion (subcutaneous Rybrevant Faspro available)
Schedule
1,050 mg (<80 kg) or 1,400 mg (≥80 kg) weekly for 5 weeks (split first dose over 2 days), then every 2 weeks; with lazertinib 240 mg daily
Dose modifications
Hold for grade 3 rash or ILD; dermatologic prophylaxis (doxycycline, moisturisers) for 12 weeks; prophylactic anticoagulation for 4 months with lazertinib
Monitoring
Infusion reactions during first dose, skin and nails, VTE symptoms, ILD

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. The subcutaneous formulation, if approved, remains clinician-administered and Part B.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments. EGFR exon 20 insertion or common EGFR mutation documented by an approved test.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2022 for EGFR exon 20 insertion NSCLC after platinum; the first NICE appraisal did not recommend it. Later combinations (with lazertinib, MARIPOSA; with chemotherapy, PAPILLON) appraised 2025-26. Check NICE.

Sources: NICE search: amivantamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 21 May 2021ApprovalUS

    Accelerated approval, EGFR exon 20 insertion NSCLC after platinum source

  2. 1 Mar 2024ApprovalUS

    First-line exon 20 insertion with chemotherapy (PAPILLON) source

  3. 19 Aug 2024ApprovalUS

    First-line EGFR-mutant NSCLC with lazertinib (MARIPOSA) source

  4. 19 Sept 2024ApprovalUS

    After osimertinib, with chemotherapy (MARIPOSA-2) source

  5. Sept 2025ApprovalUS

    Subcutaneous formulation (PALOMA-3) source

Approvals

RegionYearIndication
US2021EGFR exon 20 insertion NSCLC
US2024First-line EGFR-mutant NSCLC with lazertinib

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Rash
86%
26%
Nail toxicity
71%
11%
Infusion-related reaction
63%
6%
Musculoskeletal pain
47%
2.1%
Oedema
43%
2.6%
Stomatitis
43%
2.4%
Venous thromboembolism
36%
11%
Paraesthesia
35%
1.7%

MARIPOSA, with lazertinib. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: recommended with lazertinib for untreated EGFR-mutant NSCLC (2025) and exon 20 insertion after platinum

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
39 studies15 recruiting32 Phase 27 Phase 3
Search “Amivantamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Amivantamab
intervention: Amivantamab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Key papers

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Latest papers

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Literature trend137 papers in the last 12 months+34% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Amivantamab" OR ABSTRACT:"Amivantamab" OR TITLE:"Rybrevant" OR ABSTRACT:"Rybrevant") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Amivantamab, not a curated reading list.

Connected

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