Trastuzumab
Approved medicineAlso known as Enhertu, Herceptin, Herceptin Hylecta, Hercessi+8 more
Enhertu, Herceptin, Herceptin Hylecta, Hercessi, Herzuma, KADCYLA, Kanjinti, Ogivri, Ontruzant, Phesgo, RHUMAB HER2, Trazimera.
Recent clinical, regulatory, research and industry developments relating to this drug.
Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Metastatic breast cancer (MBC) For the treatment of adult patients with HER2-positive MBC: as monotherapy for the treatment of those patients who have received at least two… Show full indicationShow less
Metastatic breast cancer (MBC) For the treatment of adult patients with HER2-positive MBC: 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 MBC, not previously treated with trastuzumab Early breast cancer (EBC) For the treatment of adult patients with HER2-positive EBC: 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 HD201 therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. HD201 should only be used in patients with MBC or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer (MGC) In combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. HD201 should only be used in patients with MGC whose tumours have HER2 overexpression as defined by Immunohistochemistry (IHC) 2+ and a confirmatory silver-enhanced in situ hybridisation (SISH) or fluorescence in situ hybridisation (FISH) result, or by an IHC 3+ result. Accurate and validated assay methods should be used.
Indication: Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC).
Evidence ↗Indication: Metastatic breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those… Show full indicationShow less
Metastatic breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): 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 MBC, not previously treated with trastuzumab. Early breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): 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 KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Kanjinti 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 Kanjinti in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Kanjinti should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used.
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- The New England journal of medicine11
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology8
- Nature medicine5
- The oncologist4
- Clinical cancer research : an official journal of the American Association for Cancer Research3
- ESMO open3
- Curigliano G9
- Hamilton E8
- Iwata H8
- Kim SB8
- Im SA6
- Krop I6
- Tsurutani J6
- Cortés J5
- Aichi Cancer Center Hospital9
- Memorial Sloan Kettering Cancer Center8
- Asan Medical Center7
- Dana-Farber Cancer Institute7
- National Cancer Center Hospital East6
- European Institute of Oncology5
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across 17 of the same disease areas as Trastuzumab in the shared literature.
Studied across 15 of the same disease areas as Trastuzumab in the shared literature.
Studied across 11 of the same disease areas as Trastuzumab in the shared literature.
Studied across 6 of the same disease areas as Trastuzumab in the shared literature.
Studied across 10 of the same disease areas as Trastuzumab in the shared literature.
Studied across 12 of the same disease areas as Trastuzumab in the shared literature.
Studied across 6 of the same disease areas as Trastuzumab in the shared literature.
Studied across 13 of the same disease areas as Trastuzumab in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- Europe PMC — research literature
- Regulatory event sources are credited in the Regulatory Timeline above.