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.

health-canada-dpdRegulatory15 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569159) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd
CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569140) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd
CA Health Canada	—	Marketed in Canada as RYBREVANT SC (DIN 02569175) under ATC L01FX18 AMIVANTAMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 24, 2026	health-canada-dpd

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 18 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.

civicCuratedShowing 1–5 of 5 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

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.

clinicaltrialsPublishedShowing 1–40 of 40 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04487080	A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer(MARIPOSA)	active not recruiting	Phase 3	1,074	Janssen Research & Development, LLCINDUSTRY	28	Sep 28, 2026	clinicaltrials
NCT04988295	A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Epidermal growth factor receptor erbB1 inhibitor; Hepatocyte growth factor receptor inhibitor
Targets: 2 genes
UNII: 0JSR7Z0NB6
Aliases: Amivantamab, Amivantamab-vmjw, Anti-EGFR/c-Met Bispecific Antibody JNJ-61186372, CNTO-4424, CNTO4424, JNJ-611, JNJ 61186372, JNJ61186372, JNJ-6372, Rybrevant, RYBREVANT

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (12)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FX18	AMIVANTAMAB
DIN (Health Canada)	02526182	RYBREVANT
DIN (Health Canada)

EGFR Exon 19 Deletion + EGFR L858R2
Amivantamab + Carboplatin + PemetrexedCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12156 In this phase III trial, 657 patients with locally advanced or metastatic NSCLC (Non-Small Cell Lung Cancer) harbouring EGFR mutations (exon 19 deletions or L858R) were treated with amivantamab plus c… (full text at CIViC) PMID 37879444 · Passaro et al., 2024 · Open in CIViC	civic
Amivantamab + LazertinibCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12131 In this trial (MARIPOSA), 1074 patients with Non-Small Cell Lung Cancer harbouring exon 19 deletion or exon 21 L858R substitution were randomized (2:2:1) to receive lazertinib-amivantamab (n=429), osi… (full text at CIViC) PMID 38942080 · Felip et al., 2024 · Open in CIViC	civic