Drug · Monoclonal Antibody
Amivantamab
CI-DRUG-00000054Explore in graph →NCIt C124993 CHEMBL4297774 CIViC Approved
Regulatory
Approvals (15)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2025-08-14 (see label) | approved | Aug 14, 2025 | openfda |
| US FDA | — | Efficacy supplement 2024-09-19 (see label) | approved | Sep 19, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-08-19 (see label) | approved | Aug 19, 2024 | openfda |
| US FDA | — | Efficacy supplement 2024-03-01 (see label) | approved | Mar 1, 2024 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 8 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 34 | 15 | 7 | 39 | 15 | CA, EU, US | May 21, 2021 | May 24, 2016 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 21 | 7 | 4 | 24 | 5 | EU, US | May 21, 2021 | May 24, 2016 |
| Malignant Penile Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 1 | 0 | — | — | 2026-11 |
| Malignant Salivary Gland Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 1 |
Curated evidence
Clinical evidence (5)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 34339292
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| EGFR Exon 20 Insertion2 | ||||||||
| Amivantamab | Lung Non-Small Cell Carcinoma | |||||||
Clinical trials
Trials with this intervention (40)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05845671 | Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations | active not recruiting | Phase 1 / Phase 2 | 12 | University of Colorado, DenverOTHER | 1 | Sep 29, 2026 | clinicaltrials |
| NCT07107230 | A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors | recruiting | Phase 1 |