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.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Lung Non-Small Cell Carcinoma	Rybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations. in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI). in combination with carboplatin and pemetrexed for the first line treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations. as monotherapy for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum based therapy.	approved	Dec 9, 2021	ema

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 20 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 23 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