Drug · Monoclonal Antibody

Pertuzumab

CI-DRUG-00000470Explore in graph →NCIt C38692 CHEMBL2007641 CIViC Approved

Regulatory

Approvals (17)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory10 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-04-23 (see label)	approved	Apr 23, 2026	openfda
US FDA	—	Efficacy supplement 2020-01-16 (see label)	approved	Jan 16, 2020	openfda

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 15 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 4	104	43	62	230	17	CA, EU, US	Jun 8, 2012	2001-11
Malignant Breast Neoplasm	Approved	Phase 4	70	26	39	152	6	EU, US	Jun 8, 2012	2003-02
Malignant Colon Neoplasm	Phase3	Phase 3	2	1	1	4	0	—	—	2007-10
Malignant Esophageal Neoplasm	Phase3	Phase 3	2	1	1	2	0

Curated evidence

Clinical evidence (24)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–24 of 24 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
ERBB2 Amplification12
Pertuzumab + Trastuzumab

Clinical trials

Trials with this intervention (239)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 239 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
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2	6,452	National Cancer Institute (NCI)NIH	3	Sep 29, 2026	clinicaltrials
NCT05132582	A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer(HER2CLIMB-05)

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Receptor protein-tyrosine kinase erbB-2 inhibitor
Targets: 1 gene
UNII: K16AIQ8CTM
Aliases: 2C4, 2C4 Antibody, BCD-178, EG1206A, HLX11, HS627, Immunoglobulin G1, Anti-(Human V (Receptor)) (Human-Mouse Monoclonal 2C4 Heavy Chain), Disulfide With Human-Mouse Monoclonal 2C4 Kappa-Chain, Dimer, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Omnitarg perjeta, Perjeta, PERJETA, PERJETA-HERCEPTIN, Pertuzumab, Pertuzumab Biosimilar BCD-178, Pertuzumab Biosimilar EG1206A, Pertuzumab Biosimilar HLX11, Pertuzumab Biosimilar HS627, Pertuzumab Biosimilar TQB2440, Pertuzumab component of phesgo, Pertuzumab-dpzb, Pertuzumab-zzxf, PHESGO, Poherdy, RG-1273, Rhumab 2C4, RhuMAb2C4, RHUMAB 2C4, RHUMAB2C4 … (+6)

Data updated 18 hours agoSource updated unknown

Identifiers

Codes (14)

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

System	Code	Label
ATC (WHO)	L01FD02	PERTUZUMAB
ATC (WHO)

ERBB3 EXPRESSION2
Pertuzumab	Melanoma	Predictive	D	Supports Sensitivity Response	3	submitted	EID3051 A preclinical study demonstrating that in a subgroup of BRAF/NRAS wildtype/wildtype showing high levels of phospho-ErbB3, knockdown of NRG1 reduced viability and decreased activation of ErbB3, ErbB2 a… (full text at CIViC) PMID 26206558 · Capparelli et al., 2015 · Open in CIViC	civic
9F7-F11 + PertuzumabCombination	Pancreatic Ductal Adenocarcinoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID865 In mice xenografts expressing ERBB3 (HER3) the combination of ERBB2 (HER2) and ERBB3 inhibitors pertuzumab and 9F7-F11enhanced tumor inhibition and the median survival time. Sensitivity to single-agen… (full text at CIViC) PMID 25216528 · Thomas et al., 2014 · Open in CIViC	civic