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Trastuzumab emtansine (Kadcyla, T-DM1) was the first ADC for a solid tumour (2013). It is still standard after surgery for HER2+ breast cancer patients whose tumour did not fully respond to pre-surgery treatment.
Approved 2013 for pretreated HER2+ metastatic breast cancer (EMILIA) and 2019 for residual disease after neoadjuvant therapy (KATHERINE: invasive DFS HR 0.50, with OS benefit). Non-cleavable linker means no bystander effect, which explains its inferiority to T-DXd in DESTINY-Breast03 and its failure in HER2-low disease. Being displaced post-neoadjuvantly by T-DXd (DESTINY-Breast05).
Trastuzumab with lysine-conjugated DM1; released as Lys-MCC-DM1 after lysosomal degradation, cell-impermeable. Connects to HER2.
1.Antibody binds HER2 on the tumour cell surface
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9354.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA458 · SMC advice: trastuzumab emtansine. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
HER2+ metastatic breast cancer after trastuzumab and taxane (EMILIA); first ADC for a solid tumour source
Adjuvant treatment of HER2+ early breast cancer with residual disease (KATHERINE) source
Displaced post-neoadjuvantly by T-DXd approval (DESTINY-Breast05) source
| Region | Year | Indication |
|---|---|---|
| US | 2013 | HER2+ metastatic breast cancer after trastuzumab and taxane |
| US | 2019 | Adjuvant HER2+ breast cancer with residual disease after neoadjuvant therapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Fatigue | 50% | - |
| Nausea | 42% | - |
| Transaminases increased | 32% | - |
| Musculoskeletal pain | 30% | - |
| Haemorrhage | 29% | - |
| Thrombocytopenia | 29% | 6% |
| Headache | 28% | - |
| Peripheral neuropathy | 28% | - |
| Left ventricular dysfunction | 3% | - |
KATHERINE (adjuvant). Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (antibody-drug conjugates with a maytansine payload) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | genentech-access.com |
| United Kingdom | NICE: recommended for residual invasive disease after neoadjuvant therapy (TA632) and HER2+ metastatic disease (TA458) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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For HER2-positive metastatic breast cancer that has progressed after trastuzumab and a taxane, trastuzumab deruxtecan is now the standard second-line treatment and T-DM1 has moved later in the sequence. The benefit is large enough that ADC design, not just the target, is understood to be what matters. Patients need lung monitoring because of the risk of pneumonitis.
HER2-positive breast cancer is now routinely treated before surgery so that the pathology result can guide what comes after: patients with no residual cancer continue trastuzumab (with or without pertuzumab), while those with residual disease switch to T-DM1. This model of using the tumour's response as a test has since been copied in triple-negative and other cancers.
Query for this drug: (TITLE:"Trastuzumab emtansine" OR ABSTRACT:"Trastuzumab emtansine" OR TITLE:"Kadcyla" OR ABSTRACT:"Kadcyla" OR TITLE:"T-DM1" OR ABSTRACT:"T-DM1") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab emtansine, not a curated reading list.
Shares 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, KRISTINE, HERACLES, Javier Cortés.
Shares A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer, A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy, DESTINY-Breast05, HER2.
Shares Ian E. Krop, Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People Wit, Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer, Sung-Bae Kim.
Shares 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, A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy, ATEMPT, A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other.
Shares I-SPY 2, HER2 IHC 3+ (HER2-positive by immunohistochemistry), HER2-positive breast cancer with brain metastases, Breast cancer (KEGG map).
Shares A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors, Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study, CUPISCO, Roche / Genentech.
Shares Charles E. Geyer Jr., NSABP Foundation, Early HER2-positive breast cancer, HER2.
Shares HERACLES, HER2-positive breast cancer with brain metastases, Breast cancer (KEGG map), HER2.