Trastuzumab emtansine
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2013
- First approval year
- 2013
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Trastuzumab emtansine
- kadcyla
- Kadcyla
- ado trastuzumab
- ado trastuzumab emtansine
- Ado Trastuzumab Emtansine
- ado trastuzumab emtansine purple book cder
- ado trastuzumab emtansine vandf
- ado trastuzumab t emtansine t dm1
- ado trastuzumab vandf
- ADO-TRASTUZUMAB
- Ado-trastuzumab (T) emtansine (T-DM1)
- ADO-TRASTUZUMAB [VANDF]
- ado-trastuzumab emtansine
- Ado-trastuzumab emtansine
- Ado-Trastuzumab Emtansine
- Ado-trastuzumab emtansine (T-DM1)
- ADO-TRASTUZUMAB EMTANSINE [PURPLE BOOK CDER]
- ADO-TRASTUZUMAB EMTANSINE [VANDF]
- pro 132365
- PRO-132365
- pro132365
- PRO132365
- rg 3502
- RG-3502
- t dm1
- T-dm1
- T-DM1
And 33 more, listed on the interactive page.
- ATC classification codes
- L01FD03
Sources for recorded values
- CAS registry numbers
- 1018448-65-1
- ChEMBL ID
- CHEMBL1743082
- RxNorm IDs (RxCUI)
- 1371041
- FDA ingredient codes (UNII)
- SE2KH7T06F
- Applicant
- GENENTECH
- Approval date
- 22 Feb 2013
- Application number
- BLA125427
- Status
- Authorised
- Status date
- 15 Nov 2013
- Authorisation date
- 15 Nov 2013
- Approved indications
- Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy.
- Product number
- EMEA/H/C/002389
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- 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
- 5
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- trastuzumab emtansine
- Type
- Antibody
- Drug name stem
- -mab; -mab; -tansine
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Receptor protein-tyrosine kinase erbB-2 binding agent
- Action type
- BINDING_AGENT
- Target
- Receptor tyrosine-protein kinase erbB-2
- Protein identifier
- P04626
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Protein identifier
- Q9H4B7
- Mechanism
- Receptor protein-tyrosine kinase erbB-2 binding agent
- Action type
- BINDING AGENT
- Target
- Receptor tyrosine-protein kinase erbB-2
- Mechanism
- Tubulin inhibitor
- Action type
- Inhibitor
- Target
- Tubulin
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- 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
- 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
- Inflammatory Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000984
- Subject identifier
- D058922
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000521
- Subject identifier
- D012468
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001056
- Subject identifier
- D013274
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004669
- Subject identifier
- D012468
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Endometrial Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0011962
- Subject identifier
- D016889
- Condition identifier
- EFO_0000305
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_1000294
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001480
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000521
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002229
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002714
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003060
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003210
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003219
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004669
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004989
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005028
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005036
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005062
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005089
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005411
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 2
And 16 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- hepatotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- teratogenicity
- Country
- United States
- Event
- alanine aminotransferase increased
- Reports
- 149
- Reporting signal score
- 149.073
- Event
- aspartate aminotransferase increased
- Reports
- 139
- Reporting signal score
- 144.651
- Event
- asthenopia
- Reports
- 26
- Reporting signal score
- 70.1246
- Event
- blood alkaline phosphatase increased
- Reports
- 85
- Reporting signal score
- 111.812
- Event
- blood bilirubin increased
- Reports
- 64
- Reporting signal score
- 68.2208
- Event
- blood creatinine decreased
- Reports
- 32
- Reporting signal score
- 82.6317
- Event
- blood lactate dehydrogenase increased
- Reports
- 78
- Reporting signal score
- 134.75
- Event
- blood uric acid decreased
- Reports
- 25
- Reporting signal score
- 100.117
- Event
- body temperature decreased
- Reports
- 36
- Reporting signal score
- 60.3591
- Event
- breast cancer metastatic
- Reports
- 30
- Reporting signal score
- 57.3546
- Event
- breast disorder
- Reports
- 21
- Reporting signal score
- 58.7007
- Event
- breast neoplasm
- Reports
- 21
- Reporting signal score
- 68.6717
- Event
- cardiotoxicity
- Reports
- 46
- Reporting signal score
- 87.4095
- Event
- disease progression
- Reports
- 264
- Reporting signal score
- 373.982
- Event
- dyschezia
- Reports
- 17
- Reporting signal score
- 49.5879
- Event
- ejection fraction
- Reports
- 26
- Reporting signal score
- 115.812
- Event
- ejection fraction decreased
- Reports
- 106
- Reporting signal score
- 216.984
- Event
- eosinophil percentage increased
- Reports
- 24
- Reporting signal score
- 84.6261
- Event
- epistaxis
- Reports
- 150
- Reporting signal score
- 186.229
- Event
- gamma-glutamyltransferase increased
- Reports
- 55
- Reporting signal score
- 52.1516
- Event
- gingival bleeding
- Reports
- 39
- Reporting signal score
- 58.9427
- Event
- hepatic cirrhosis
- Reports
- 43
- Reporting signal score
- 60.158
- Event
- hepatopulmonary syndrome
- Reports
- 13
- Reporting signal score
- 65.8671
- Event
- hepatotoxicity
- Reports
- 56
- Reporting signal score
- 68.2855
- Event
- her-2 positive breast cancer
- Reports
- 16
- Reporting signal score
- 70.3871
And 25 more, listed on the interactive page.
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- NCT01904903
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- NCT01983501
- NCT02038010
And 61 more, listed on the interactive page.
- Dose
- 3.6 mg/kg
- Route
- Intravenous
- How often
- Every 3 weeks
- Adjust schedule to maintain 3-week interval.
- Administer infusion over 90 minutes for the first infusion.
- Administer subsequent infusions over 30 minutes if prior infusions were well tolerated.
- Do not administer at doses greater than 3.6 mg/kg.
- Do not re-escalate dose after reduction.
- If dose is delayed or missed, administer as soon as possible, maintaining schedule.
- Observe during and after infusions for adverse reactions.
- Permanently discontinue for life-threatening reactions.
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGFNIKDTYIHWVRQAPGKGLEWVARIYPTNGYTRYADSVKGRFTISADTSKNTAYLQMNSLRAEDTAVYYCSRWGGDGFYAMDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSLSASVGDRVTITCRASQDVNTAVAWYQQKPGKAPKLLIYSASFLYSGVPSRFSGSRSGTDFTLTISSLQPEDFATYYCQQHYTTPPTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 50242-087
- 50242-088
Related records
Trials (207)
- 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
- A Bioavailability Study of GS1-144 Tablets in Healthy Postmenopausal Women
- A Bioavailability Study of Two Different PEG-rhGH Preparations.
- A Bioequivalence Study of Two Different PEG-rhGH Preparations
- A Bioequivalence Study of Two Different PEG-rhGH Preparations.
- A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations
- A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502
- A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
- A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)
- A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
- A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed
- A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B
- 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 I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants
- A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB)
- A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
- A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
- A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.
- A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B
- A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
Approved for (6)
- Breast cancer
- Breast carcinoma
- Breast neoplasm
- Cancer
- HER2 positive breast carcinoma
- Neoplasm
In development for (7)
- Endometrial cancer Phase 1
- Gastric cancer Phase 2
- Inflammatory breast carcinoma Phase 3
- Non-small cell lung carcinoma Phase 2
- Plasma cell myeloma Phase 2
- Salivary gland cancer Phase 2
- Salivary gland carcinoma Phase 2
Targets (16)
- ERBB2 Receptor protein-tyrosine kinase erbB-2 binding agent
- TUBA1A Tubulin inhibitor
- TUBA1B Tubulin inhibitor
- TUBA1C Tubulin inhibitor
- TUBA3C Tubulin inhibitor
- TUBA3E Tubulin inhibitor
- TUBA4A Tubulin inhibitor
- TUBB Tubulin inhibitor
- TUBB1 Tubulin inhibitor
- TUBB2A Tubulin inhibitor
- TUBB2B Tubulin inhibitor
- TUBB3 Tubulin inhibitor
- TUBB4A Tubulin inhibitor
- TUBB4B Tubulin inhibitor
- TUBB6 Tubulin inhibitor
- TUBB8 Tubulin inhibitor