KANJINTI (trastuzumab-anns)
KANJINTI is indicated for the treatment of Breast Cancer; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma.
How KANJINTI Works
Kanjinti targets the HER2 proto-oncogene, which encodes a 185 kDa transmembrane receptor protein related to the epidermal growth factor receptor. The drug binds to these receptors to inhibit the proliferation of human tumor cells that overexpress HER2. Furthermore, it functions as a mediator of antibody-dependent cellular cytotoxicity (ADCC). This immune-mediated response preferentially exerts its effects on HER2-overexpressing cancer cells compared to cells that do not overexpress the receptor.
Details
- Status
- Prescription
- First Approved
- 2019-06-13
- Revenue
- $42M (Q4-2023)
- Routes
- SINGLE-DOSE, MULTIDOSE
- Dosage Forms
- VIAL
KANJINTI Approval History
What KANJINTI Treats
3 indicationsKANJINTI is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
KANJINTI Boxed Warning
CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discont...
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue KANJINTI for cardiomyopathy. ( 2.5 , 5.1 ) Infusion Reactions, Pulmonary Toxicity: Discontinue KANJINTI for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. ( 5.2 , 5.4 ) Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. ( 5.3 , 8.1 , 8.3 ) Cardiomyopathy Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with KANJINTI. Discontinue KANJINTI treatment in patients receiving adjuvant therapy and withhold KANJINTI in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ]. Infusion Reactions; Pulmonary Toxicity Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration of trastuzumab products. Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue KANJINTI for anap
KANJINTI 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.
KANJINTI is a lower-cost alternative to Herceptin with no clinically meaningful differences. Requires prescriber approval to substitute.
KANJINTI 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 KANJINTI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications KANJINTI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to KANJINTI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
418 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) |
| NCT04379596 DG-03 | D967LC00001 2019-004483-22 | Ph 2 | recruiting | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) |
| NCT05672524 | 22-185 | Ph 2 | recruiting | A Study of Tucatinib and Trastuzumab in People With Rectal Cancer |
| NCT06764875 | D702AC00001 2024-512583-57-00 | Ph 3 | recruiting | A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer |
| NCT02320435 | MO29406 2014-002048-42, 2023-505102-42-00 | Ph 3 | active not recruiting | A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial |
| NCT07413939 BREnnA | WO46069 2025-524498-17-00 | Ph 2, Ph 3 | recruiting | RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive |
| 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 |
| NCT05319873 | 21-001819 NCI-2021-11707 | Ph 1, Ph 2 | active not recruiting | Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer |
| NCT03179904 results posted | MC1633 W81XWH-16-1-0269, W81XWH-16-1-0268 | Ph 2 | active not recruiting | TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic 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 |
| 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 |
| NCT07214766 | GP44770 | Ph 1 | active not recruiting | A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants |
| 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 |
| NCT07102381 EmpowHER 208 | JZP598-208 2025-523204-68-00 | Ph 2 | recruiting | A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer |
| NCT06589830 | TL-HER-202301 | Ph 2 | recruiting | TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer |
| NCT05187182 | 202202027 | Ph 1 | recruiting | CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer |
| NCT03417544 results posted | 17-546 | Ph 2 | active not recruiting | Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC |
| NCT07402473 EUREKA | 042507 Pro2025002581 | Ph 2 | recruiting | Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer |
| NCT07545044 | JSKN003-008 | Ph 2 | not yet recruiting | A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer |
| NCT05132582 HER2CLIMB-05 | SGNTUC-028 C4251007, 2023-503826-37-00 | Ph 3 | active not recruiting | A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer |
| NCT03820141 DTP results posted | Pro00020917 | Ph 2 | active not recruiting | Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer |
| NCT05152147 HERIZON-GEA-01 | ZWI-ZW25-301 2021-000296-36, jRCT2061230026 | Ph 3 | active not recruiting | A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers |
| NCT04661150 results posted | ML42058 | Ph 2 | active not recruiting | A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction |
| NCT07528898 | OBU-BC-II-279 | Ph 2 | not yet recruiting | Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study. |
| NCT06136897 results posted | NCI-2023-09506 NCI-2023-09506, EAY131-J | Ph 2 | active not recruiting | Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) |
| NCT02705859 Panther | ICORG 15-02 | Ph 1 | completed | Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study) |
| NCT07007559 ASPEN-09-03 | AT148009 | Ph 2 | recruiting | ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer |
| NCT06625775 | TBBO10203-101 2024-519445-29-00, BREAKER-101 | Ph 1 | recruiting | Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors |
| 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 |
| NCT07441460 | KN026-007 | Ph 3 | recruiting | A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer |
| NCT04886531 | HCRN BRE17-141 | Ph 2 | recruiting | Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers |
| NCT07518173 | BL-M07D1-307 | Ph 3 | not yet recruiting | A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer |
| NCT05253651 MOUNTAINEER-03 | SGNTUC-029 C4251008, 2024-514180-25-00 | Ph 3 | recruiting | A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer |
| NCT07216105 | FT836-101 | Ph 1 | recruiting | FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors |
| NCT05785741 | DB-1310-O-1001 CTR20231736 | Ph 1, Ph 2 | recruiting | A Study of DB-1310 in Advanced/Metastatic Solid Tumors |
| NCT05458674 | 02AB21-TucErBit | Ph 2 | recruiting | Tucatinib+Trastuzumab+Eribulin in HER2+ MBC |
| NCT04208178 EPIK-B2 | CBYL719G12301 2024-512050-13-00 | Ph 3 | active not recruiting | Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation |
| NCT05515796 | DP-GE-ICI | Ph 2 | completed | Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors |
| NCT05378464 | MCC-21378 | Ph 1 | recruiting | Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer |
| NCT06031233 MINUTE | NL83071.075.22 / 20221102 | Ph 4 | recruiting | Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie |
| NCT07335081 | RJBC2401 | Ph 2 | recruiting | ctDNA in HER2+ EBC Neoadjuvant Treatment |
| NCT02654119 results posted | 0318-15-FB NCI-2015-01879, P30CA036727 | Ph 2 | completed | Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery |
| NCT05323955 BRIDGET | Pro00109777 | Ph 2 | active not recruiting | Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib |
| NCT06731478 | DS8201-724 KEYNOTE-G03, MK-3475-G03 | Ph 3 | recruiting | Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer |
| NCT04253561 IPATHER | SOLTI-1507 2019-001526-94 | Ph 1 | completed | Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients |
| NCT01613482 TSARINE | TSARINE-0602 | Ph 3 | terminated | TraStuzumAb-Radiotherapy : Impact on the Cerebral Prevention |
| NCT03006172 | GO39374 2016-003022-17, 2023-508124-36-00 | Ph 1 | active not recruiting | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer |
| NCT05733689 | 1977 UCI 21-191 | Ph 1 | recruiting | Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) |
| NCT04285671 | 19-002190 NCI-2020-00677 | Ph 1, Ph 2 | active not recruiting | Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer |
| 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 |
Showing 50 of 418 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.
KANJINTI FDA Label Details
Indications & Usage
FDA Label (PDF)KANJINTI is indicated for the treatment of Breast Cancer; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma.
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning Cardiomyopathy: Trastuzumab products can result in subclin...
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Revenue Insights
- • Q4-2023: $42M
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Trial Analysis
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Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.