Trastuzumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
1998
- First approval year
- 1998
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Trastuzumab
- herceptin
- Herceptin
- herwenda
- Herwenda
- herzuma
- Herzuma
- kadcyla
- Kadcyla
- kanjinti
- Kanjinti
- ogivri
- Ogivri
- ontruzant
- Ontruzant
- trastuzumab component of herceptin hylecta
- Trastuzumab component of herceptin hylecta
- trastuzumab component of phesgo
- Trastuzumab component of phesgo
- trazimera
- Trazimera
- zercepac
- Zercepac
- 4d5v8
- 4D5V8
- abi 007 carboplatin trastuzumab
- abp 980
- ABP 980
- abp 980 trastuzumab biosimilar
- ABP-980
- Abp-980 (trastuzumab biosimilar)
- abp980
- ABP980
- bmab 200
- Bmab-200
- canhera
- Canhera
- ct p6
- CT-P6
- ctp 6
- CTP-6
- ctp6
- CTP6
- dmb 3111
- dmb 3111 trastuzumab biosimilar
- Dmb-3111
- DMB-3111
- DMB-3111 (TRASTUZUMAB BIOSIMILAR)
And 182 more, listed on the interactive page.
- CAS registry numbers
- 180288-69-1
- ChEMBL ID
- CHEMBL1201585
- FDA ingredient codes (UNII)
- P188ANX8CK
- L01FD01
- L01XC03
Sources for recorded values
- 224905
- 2174802
- Applicant
- GENENTECH
- Approval date
- 25 Sept 1998
- Application number
- BLA103792
- Status
- Authorised
- Status date
- 28 Aug 2000
- Authorisation date
- 28 Aug 2000
- Approved indications
- Breast cancer Metastatic breast cancer Herceptin is indicated for the treatment of patients with HER2-positive metastatic breast cancer: as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone-receptor-positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments; in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable; in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease; in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive metastatic breast cancer, not previously treated with trastuzumab. Early breast cancer Herceptin is indicated for the treatment of patients with HER2-positive early breast cancer: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable); following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin; in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. Herceptin should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease. Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result. Accurate and validated assay methods should be used.
- Product number
- EMEA/H/C/000278
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 8
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Breast Neoplasms
- Stomach Neoplasms
European medicines record
- Patents
- 0
- Designations
- 3
- Earliest recorded loss of exclusivity
- 20 Oct 2017
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- trastuzumab
- 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
- 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
- Stomach Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000178
- Subject identifier
- D013274
- Condition
- Hodgkin Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Carcinoma, Intraductal, Noninfiltrating
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000432
- Subject identifier
- D002285
- Condition
- Adenocarcinoma, Follicular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000501
- Subject identifier
- D018263
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Insulinoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000549
- Subject identifier
- D007340
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Osteosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000637
- Subject identifier
- D012516
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000641
- Subject identifier
- D013964
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Skin Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000701
- Subject identifier
- D012871
- 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
- Lymphoma, T-Cell, Cutaneous
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002913
- Subject identifier
- D016410
- 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
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003860
- Subject identifier
- D010190
And 60 more, listed on the interactive page.
- Condition identifier
- EFO_0000199
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000305
- Condition identifier
- EFO_0000313
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000432
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000503
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002916
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0003897
- Condition identifier
- EFO_0004920
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005221
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005774
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005922
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006318
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006859
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006861
- Condition identifier
- EFO_0008549
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009483
- Condition identifier
- EFO_0009708
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000028
- Highest recorded phase
- 1
And 104 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Warning
- Black Box Warning
- Effect
- infectious disease
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Event
- bone marrow failure
- Reports
- 518
- Reporting signal score
- 627.815
- Event
- cardiac dysfunction
- Reports
- 176
- Reporting signal score
- 446.392
- Event
- cardiac failure
- Reports
- 580
- Reporting signal score
- 422.78
- Event
- cardiotoxicity
- Reports
- 568
- Reporting signal score
- 1,337.05
- Event
- chills
- Reports
- 821
- Reporting signal score
- 507.209
- Event
- diarrhoea
- Reports
- 3,144
- Reporting signal score
- 1,305.6
- Event
- disease progression
- Reports
- 1,368
- Reporting signal score
- 1,449.16
- Event
- ejection fraction decreased
- Reports
- 1,161
- Reporting signal score
- 2,774.87
- Event
- febrile neutropenia
- Reports
- 950
- Reporting signal score
- 895.481
- Event
- left ventricular dysfunction
- Reports
- 260
- Reporting signal score
- 448.065
- Event
- metastases to bone
- Reports
- 335
- Reporting signal score
- 512.227
- Event
- metastases to central nervous system
- Reports
- 698
- Reporting signal score
- 1,720.54
- Event
- metastases to liver
- Reports
- 316
- Reporting signal score
- 471.591
- Event
- metastases to lung
- Reports
- 252
- Reporting signal score
- 417.155
- Event
- mucosal inflammation
- Reports
- 484
- Reporting signal score
- 504.784
- Event
- myelosuppression
- Reports
- 990
- Reporting signal score
- 2,544.9
- Event
- neuropathy peripheral
- Reports
- 944
- Reporting signal score
- 695.566
- Event
- neutropenia
- Reports
- 1,133
- Reporting signal score
- 550.488
- Event
- palmar-plantar erythrodysaesthesia syndrome
- Reports
- 629
- Reporting signal score
- 906.401
- NCT00003440
- NCT00003539
- NCT00003612
- NCT00003992
- NCT00004013
- NCT00004067
- NCT00004074
- NCT00004888
- NCT00004925
- NCT00005635
- NCT00006104
- NCT00006108
- NCT00006110
- NCT00006123
- NCT00006228
- NCT00006381
- NCT00006825
- NCT00009997
- NCT00014430
- NCT00019812
- NCT00024154
- NCT00033514
- NCT00036868
- NCT00038402
- NCT00039455
And 399 more, listed on the interactive page.
- Dose
- 4 mg/kg, then 2 mg/kg, then 6 mg/kg, or 8 mg/kg initial, then 6 mg/kg
- Route
- Intravenous
- How often
- Weekly for 12 or 18 weeks, then every 3 weeks for a total of 52 weeks, or until disease progression
- Check vial labels to ensure correct drug
- Do not administer as an IV push or bolus
- Do not mix with other drugs
- Use infusion only
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFNIKDTYIHWVRQAPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCSRWGGDGFYAMDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCRASQDVNTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQPEDFATYYCQQHYTTPPTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 0069-0305
- 0069-0308
- 50242-077
- 50242-132
- 50242-245
- 50242-260
- 55513-132
- 55513-141
- 63459-303
- 63459-305
- 78206-147
- 78206-148
- 83257-001
- 83257-003
- 83257-004
Related records
Trials (996)
- "Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "
- "Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
- 12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
- 1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
- 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
- 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
- 64-Cu Labeled Brain PET/MRI for MM-302 in Advanced HER2+ Cancers With Brain Mets
- 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
- 89ZrTrastuzumab Breast Imaging With Positron Emission Tomography
- A Clinical Study Comparing Anti-HER2 Therapy Combined With Chemotherapy to Chemotherapy Alone as Adjuvant Therapy Following Surgery for Stage IB-II Gastric Cancer With High HER2 Expression.
- 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 Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
- A Continuation Study of Herceptin (Trastuzumab) in Participants With Metastatic or Locally Advanced 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 Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
- A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
- A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer
- A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer
- A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer
Approved for (10)
- Breast cancer
- Breast carcinoma
- Breast neoplasm
- Cancer
- Gastric adenocarcinoma
- Gastric cancer
- Gastric carcinoma
- Gastric neoplasm
- HER2 positive breast carcinoma
- Neoplasm
In development for (74)
- Acute myeloid leukemia Phase 2
- Adenocarcinoma Phase 2
- Adrenal cortex carcinoma Phase 1
- Angiosarcoma Phase 2
- Anus cancer Phase 1
- Appendix carcinoma Phase 1
- Bile duct carcinoma Phase 2
- Biliary tract cancer Phase 3
- Biliary tract neoplasm Phase 3
- Brain disorder Phase 3
- Breast carcinoma in situ Phase 2
- Breast disorder Phase 1
- Breast ductal adenocarcinoma Phase 2
- Carcinoid tumor Phase 1
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 3
- Cervical cancer Phase 1
- Cholangiocarcinoma Phase 2
- Colon carcinoma Phase 2
- Colorectal cancer Phase 3
Other linked conditions (1)
- Female breast carcinoma
Targets (1)
- ERBB2 Receptor protein-tyrosine kinase erbB-2 inhibitor