Pertuzumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2012
- First approval year
- 2012
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Pertuzumab
- omnitarg
- Omnitarg
- omnitarg perjeta
- Omnitarg perjeta
- perjeta
- Perjeta
- pertuzumab component of phesgo
- Pertuzumab component of phesgo
- capecitabine trastuzumab and pertuzumab
- CN-Perjeta(Pertuzumab)
- EU-Perjeta(Pertuzumab)
- hlx 11
- HLX-11
- hlx11
- HLX11
- immunoglobulin g1 anti human neu receptor human mouse monoclonal 2c4 heavy chain disulfide with human mouse monoclonal 2c4 kappa chain dimer
- immunoglobulin g1 anti human neu receptor human mouse monoclonal 2c4 heavy chain disulphide with human mouse monoclonal 2c4 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN NEU (RECEPTOR)) (HUMAN-MOUSE MONOCLONAL 2C4 HEAVY CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL 2C4 .KAPPA.-CHAIN, DIMER
- IMMUNOGLOBULIN G1, ANTI-(HUMAN NEU (RECEPTOR)) (HUMAN-MOUSE MONOCLONAL 2C4 HEAVY CHAIN), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL 2C4 .KAPPA.-CHAIN, DIMER
- Perjeta
- Perjeta ®
- Perjeta®
- pertuzumab
- Pertuzumab
- PERTUZUMAB
- PERTUZUMAB (GENETICAL RECOMBINATION)
- Pertuzumab (neoadjuvant)
- Pertuzumab (or biosimilar)
- Pertuzumab (rhuMAb 2C4)
- Pertuzumab (ZRC-3277)
- pertuzumab [INN]
- PERTUZUMAB [JAN]
- PERTUZUMAB [MART.]
And 45 more, listed on the interactive page.
- ATC classification codes
- L01FD02
Sources for recorded values
- CAS registry numbers
- 380610-27-5
- ChEMBL ID
- CHEMBL2007641
- FDA ingredient codes (UNII)
- K16AIQ8CTM
- 1298944
- 2382597
- Applicant
- GENENTECH
- Approval date
- 8 Jun 2012
- Application number
- BLA125409
- Status
- Authorised
- Status date
- 4 Mar 2013
- Authorisation date
- 4 Mar 2013
- Approved indications
- Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
- Product number
- EMEA/H/C/002547
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 1
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Breast Neoplasms
European medicines record
- Patents
- 0
- Designations
- 2
- Earliest recorded loss of exclusivity
- 8 Jun 2024
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- pertuzumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- erb-b2 receptor tyrosine kinase 2
- Gene symbol
- ERBB2
- Protein identifier
- P04626
- Median affinity
- 8
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Receptor protein-tyrosine kinase erbB-2 inhibitor
- Action type
- Inhibitor
- Target
- Receptor tyrosine-protein kinase erbB-2
- Protein identifier
- P04626
Open Targets mechanisms
- Mechanism
- Receptor protein-tyrosine kinase erbB-2 inhibitor
- Action type
- Inhibitor
- Target
- Receptor tyrosine-protein kinase erbB-2
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Hematologic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001642
- Subject identifier
- D019337
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002916
- Subject identifier
- D004938
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Hemangiosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003968
- Subject identifier
- D006394
- Condition
- Breast Neoplasms, Male
- Highest recorded phase
- 1
- Condition identifier
- EFO:0006861
- Subject identifier
- D018567
- Condition
- Breast Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009483
- Subject identifier
- D001941
- Condition
- Neoplasm Metastasis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009708
- Subject identifier
- D009362
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000294
- Subject identifier
- D001943
- Condition
- Rectal Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:1000657
- Subject identifier
- D012004
- Condition
- Inflammatory Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000984
- Subject identifier
- D058922
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001056
- Subject identifier
- D013274
- Condition
- Peritoneal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002087
- Subject identifier
- D010534
- Condition
- Carcinoma, Neuroendocrine
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002120
- Subject identifier
- D018278
- Condition
- Fallopian Tube Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002158
- Subject identifier
- D005185
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005575
- Subject identifier
- D015179
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007576
- Subject identifier
- D004938
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0008170
- Subject identifier
- D010051
And 2 more, listed on the interactive page.
- Condition identifier
- EFO_0000305
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0002916
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0004920
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009483
- Condition identifier
- EFO_1000294
- Condition identifier
- EFO_1001480
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000521
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002120
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002169
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002447
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0003060
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003219
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004669
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004970
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004971
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004989
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004992
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005023
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005028
- Highest recorded phase
- 3
And 32 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Event
- alopecia
- Reports
- 296
- Reporting signal score
- 193.471
- Event
- bone marrow failure
- Reports
- 513
- Reporting signal score
- 650.517
- Event
- breast cancer recurrent
- Reports
- 159
- Reporting signal score
- 368.301
- Event
- cardiac dysfunction
- Reports
- 175
- Reporting signal score
- 455.304
- Event
- cardiac failure
- Reports
- 547
- Reporting signal score
- 404.884
- Event
- cardiotoxicity
- Reports
- 544
- Reporting signal score
- 1,296.28
- Event
- chills
- Reports
- 769
- Reporting signal score
- 479.404
- Event
- diarrhoea
- Reports
- 3,097
- Reporting signal score
- 1,412.3
- Event
- disease progression
- Reports
- 1,332
- Reporting signal score
- 1,464.88
- Event
- ejection fraction decreased
- Reports
- 1,142
- Reporting signal score
- 2,792.86
- Event
- febrile neutropenia
- Reports
- 932
- Reporting signal score
- 920.981
- Event
- hypokalaemia
- Reports
- 199
- Reporting signal score
- 155.692
- Event
- infusion related reaction
- Reports
- 556
- Reporting signal score
- 371.993
- Event
- interstitial lung disease
- Reports
- 233
- Reporting signal score
- 218.944
- Event
- left ventricular dysfunction
- Reports
- 252
- Reporting signal score
- 444.085
- Event
- metastases to bone
- Reports
- 318
- Reporting signal score
- 492.311
- Event
- metastases to central nervous system
- Reports
- 635
- Reporting signal score
- 1,551.77
- Event
- metastases to liver
- Reports
- 302
- Reporting signal score
- 458.317
- Event
- metastases to lung
- Reports
- 245
- Reporting signal score
- 415.75
- Event
- mucosal inflammation
- Reports
- 476
- Reporting signal score
- 519.457
- Event
- myelosuppression
- Reports
- 913
- Reporting signal score
- 2,339.68
- Event
- neuropathy peripheral
- Reports
- 896
- Reporting signal score
- 674.939
- Event
- neutropenia
- Reports
- 1,106
- Reporting signal score
- 575.803
- Event
- palmar-plantar erythrodysaesthesia syndrome
- Reports
- 618
- Reporting signal score
- 921.823
- Event
- peripheral sensory neuropathy
- Reports
- 95
- Reporting signal score
- 167.12
And 4 more, listed on the interactive page.
- NCT00027027
- NCT02320435
- NCT02490475
- NCT02494596
- NCT02593708
- NCT02925234
- NCT04341181
- NCT05150691
- NCT05159245
- NCT06136897
- NCT00058539
- NCT02480010
- NCT00058552
- NCT00096993
- NCT01684878
- NCT02004093
- NCT00063154
- NCT00855894
- NCT02507375
- NCT03845270
- NCT00096941
- NCT03498521
- NCT04551521
- NCT04632992
- NCT00301899
And 173 more, listed on the interactive page.
- Dose
- 840 mg (initial), 420 mg (subsequent)
- Route
- Intravenous
- How often
- Every 3 weeks
- Administer as a 30 to 60-minute infusion for subsequent doses
- Administer as a 60-minute infusion for initial dose
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 50242-145
- 50242-245
- 50242-260
Related records
Trials (315)
- "Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "
- 1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
- A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
- A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
- A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)
- A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
- A Multiple-Dose Study of RhuMab 2C4 and Docetaxel in the Treatment of Advanced Solid Tumors
- A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
- A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
- A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
- A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
- A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
- A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma
- A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
- A Phase Ib, Open-label, Multicenter Study of the Safety and PK of the Combination of rhuMAb2c4 (Omnitarg), a Recombinant Humanized Antibody to HER2, and Capecitabine (Xeloda) in Patients With Advanced Solid Tumors
- A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site
- A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors
- A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer
- A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
- A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
Approved for (6)
- Breast cancer
- Breast carcinoma
- Breast neoplasm
- Cancer
- HER2 positive breast carcinoma
- Neoplasm
In development for (20)
- Angiosarcoma Phase 2
- Breast disorder Phase 1
- Carcinoma of esophagus Phase 3
- Colorectal adenocarcinoma Phase 2
- Colorectal cancer Phase 2
- Esophageal cancer Phase 3
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 2
- Gastric cancer Phase 3
- Inflammatory breast carcinoma Phase 3
- Lymphoid neoplasm Phase 2
- Male breast carcinoma Phase 1
- Malignant colon neoplasm Phase 1
- Neuroendocrine carcinoma Phase 2
- Non-small cell lung carcinoma Phase 2
- Ovarian cancer Phase 3
- Peritoneum cancer Phase 2
- Prostate cancer Phase 2
- Prostate carcinoma Phase 2
- Rectal cancer Phase 1
Targets (1)
- ERBB2 Receptor protein-tyrosine kinase erbB-2 inhibitor