KADCYLA (ado-trastuzumab emtansine)
Kadcyla is a HER2-targeted antibody and microtubule inhibitor conjugate indicated as a single agent for the treatment of HER2-positive breast cancer. It is used in patients with metastatic disease who have previously received trastuzumab and a taxane, as well as for the adjuvant treatment of patients with early breast cancer who have residual invasive disease after neoadjuvant therapy. Treatment is restricted to patients identified by an FDA-approved companion diagnostic. This therapy serves as a targeted option for patients who have already undergone specific prior treatment regimens.
How KADCYLA Works
This antibody-drug conjugate combines the anti-HER2 antibody trastuzumab with DM1, a small molecule microtubule inhibitor. Upon binding to the HER2 receptor, the conjugate is internalized and degraded within the cell, releasing cytotoxic catabolites that disrupt microtubule networks and cause cell death. Additionally, the drug inhibits HER2 receptor signaling and mediates antibody-dependent cell-mediated cytotoxicity. These combined actions target and eliminate cells that overexpress the HER2 protein.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-02-22
- Revenue
- $583M (Q4-2025)
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
KADCYLA Approval History
What KADCYLA Treats
1 indicationsKADCYLA is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
KADCYLA Boxed Warning
HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin. ( 2.3 , 5.1 ) Cardiac Toxicity: KADCYLA administration may lead to reductions in left ventr...
WARNING: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin. ( 2.3 , 5.1 ) Cardiac Toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular function. ( 2.3 , 5.2 ) Embryo-Fetal Toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception. ( 5.3 , 8.1 , 8.3 ) WARNING: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning Hepatotoxicity, liver failure and death have occurred in KADCYLA-treated patients. Monitor hepatic function prior to initiation and prior to each dose. Institute dose modifications or permanently discontinue as appropriate. ( 2.3 , 5.1 ) KADCYLA may lead to reductions in left ventricular ejection fraction (LVEF). Assess LVEF prior to initiation. Monitor and withhold dosing or discontinue as appropriate. ( 2.3 , 5.2 ) Embryo-Fetal Toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception. ( 5.3 , 8.1 , 8.3 )
KADCYLA Target & Pathway
ProTarget
A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.
Pathway Context
HER2 forms dimers with other HER family members to activate growth signaling
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
KADCYLA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in KADCYLA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KADCYLA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KADCYLA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
63 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT07578116 | S2511 NCI-2026-02627, S2511 | Ph 3 | not yet recruiting | Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis |
| NCT04439110 results posted | NCI-2020-02979 NCI-2020-02979, EAY131-Q | Ph 2 | active not recruiting | Testing Ado-Trastuzumab Emtansine as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol Q) |
| NCT04589845 | BO41932 2020-001847-16, 2023-507418-28-00 | Ph 2 | active not recruiting | Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study |
| NCT06595563 ZEPHIR-02 | IJB-ZEPHIR02-2024 | Ph 2 | recruiting | HER2 Molecular Imaging With 89Zr-trastuzumab PET/CT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer |
| NCT04266249 | EA1181 NCI-2019-07439, EA1181 | Ph 2 | active not recruiting | CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy |
| NCT02314481 DARWINII | 14/0274 | Ph 2 | completed | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity |
| NCT05408845 | NRG-HN010 NCI-2022-04353, NRG-HN010 | Ph 2 | recruiting | Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers |
| NCT06324357 | 1479-0012 | Ph 1, Ph 2 | recruiting | 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 With Different Types of HER2+ Cancer That Has Spread |
| NCT02390427 | 15-024 | Ph 1 | completed | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer |
| NCT04486352 EndoMAP | AFT-50 | Ph 1, Ph 2 | recruiting | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer |
| NCT04931342 BOUQUET | WO42178 GOG-3051, ENGOT-GYN2 | Ph 2 | active not recruiting | A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors |
| NCT02675829 | 15-335 | Ph 2 | active not recruiting | Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers |
| NCT04873362 Astefania | WO42633 2020-003681-40, 2023-503568-18-00 | Ph 3 | active not recruiting | 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 |
| NCT01853748 results posted | 13-048 | Ph 2 | completed | T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) |
| NCT06348134 | IRB23-0502 | Ph 2 | recruiting | Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery |
| NCT05415215 ProHer results posted | MO43110 2021-002346-33, 2023-506380-33-00 | Ph 3 | completed | A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer |
| NCT01494662 results posted | 11-344 TBCRC 022 | Ph 2 | completed | HKI-272 for HER2-Positive Breast Cancer and Brain Metastases |
| NCT05673928 | 2021-0899 NCI-2022-11157 | Ph 2 | recruiting | 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) |
| NCT00781612 | TDM4529g BO25430, 2010-021067-32 | Ph 2 | active not recruiting | 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 |
| NCT04457596 | A011801 NCI-2020-03770, U10CA180821 | Ph 3 | active not recruiting | T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial |
| NCT04419181 | UBRS20013 | Ph 2 | withdrawn | Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer |
| NCT04740918 KATE3 results posted | MO42319 2020-002818-41 | Ph 3 | terminated | A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) |
| NCT04341181 ProTarget | ProTarget | Ph 2 | recruiting | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling |
| NCT01772472 results posted | BO27938 2012-002018-37 | Ph 3 | completed | A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) |
| NCT04042051 Panthera | CTRIAL-IE 17-13 | Ph 1 | terminated | Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer |
| NCT05650879 HER2 | ELVN-002-001 | Ph 1 | active not recruiting | ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer |
| NCT06126640 | SHR-A1811-305 | Ph 3 | recruiting | 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 |
| NCT04680442 SCHOLAR-2 | PHRI.SCHOLAR-2 | Ph 2 | recruiting | Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction |
| NCT04632992 MyTACTIC results posted | ML42439 | Ph 2 | completed | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response |
| NCT04675827 Decrescendo | IJB-EBC-Decrescendo-2020 | Ph 2 | terminated | De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade |
| NCT03726879 IMpassion050 results posted | BO40747 | Ph 3 | completed | A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer |
| NCT06313086 | SYSA1501-009 CTR20240245 | Ph 3 | recruiting | DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer |
| NCT01120184 results posted | BO22589 2009-017905-13 | Ph 3 | completed | A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT03084939 | BO29919 | Ph 3 | completed | Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer |
| NCT03784599 TRAEMOS | M18TEO | Ph 2 | terminated | T-DM1 and Osimertinib Combination Treatment to Target HER2 Bypass Track Resistance in EGFR Mutation Positive NSCLC |
| NCT03364348 results posted | IRB-37299 NCI-2016-01881, BRS0070 | Ph 1 | completed | 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer |
| NCT01966471 results posted | BO28407 2012-004902-82 | Ph 3 | completed | A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer |
| NCT04351230 | ACCRU-BR-1801 NCI-2020-02218, ACCRU-BR-1801 | Ph 2 | withdrawn | T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer |
| NCT01702571 results posted | MO28231 2012-001628-37 | Ph 3 | completed | A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment |
| NCT04296942 results posted | 200056 20-C-0056 | Ph 1 | terminated | BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) |
| NCT04298918 results posted | CO41863 2019-004200-35 | Ph 1, Ph 2 | terminated | A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer |
| NCT03894007 PREDIXIIHER2 | PREDIX II HER2 2018-004457-24 | Ph 2 | terminated | Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer |
| NCT02658734 results posted | ML29662 | Ph 4 | completed | A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane |
| NCT02924883 KATE2 results posted | WO30085 2015-004189-27 | Ph 2 | completed | A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy |
| NCT02038010 results posted | NU 13B06 NCI-2013-02224, NU 13B06 | Ph 1 | completed | BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx |
| NCT02605915 | GO29831 2015-002113-29 | Ph 1 | completed | Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer |
| NCT02318901 PembroMab results posted | PembroMab | Ph 1, Ph 2 | terminated | Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer |
| NCT02999672 KAMELEON results posted | MO29694 2015-001377-40 | Ph 2 | completed | A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors |
Showing 50 of 63 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KADCYLA FDA Label Details
Indications & Usage
FDA Label (PDF)KADCYLA is indicated for the treatment of Breast Cancer.
WARNING: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA ...
Pro Intelligence Preview
Deep insights for KADCYLA
Revenue Insights
- • Q4-2025: $583M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 66 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment