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KANJINTI (TRASTUZUMAB-ANNS)
KANJINTI (generic name: TRASTUZUMAB-ANNS) is a HER2/neu Receptor Antagonist [EPC] drug developed by AMGEN INC. It is currently FDA-approved for Adjuvant Breast Cancer, Metastatic Breast Cancer - First Line, Metastatic Breast Cancer - Subsequent Therapy.
KANJINTI is a biosimilar of trastuzumab, an antibody that inhibits the receptor tyrosine-protein kinase erbB-2. It is used to treat HER2/Neu Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IA Breast Cancer AJCC v7, and Stage IB Breast Cancer AJCC v7, often in combination with chemotherapy such as cyclophosphamide, docetaxel, and doxorubicin.
At a glance
| Generic name | TRASTUZUMAB-ANNS |
|---|---|
| Sponsor | AMGEN INC |
| Drug class | HER2/neu Receptor Antagonist [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Adjuvant Breast Cancer
- Metastatic Breast Cancer - First Line
- Metastatic Breast Cancer - Subsequent Therapy
- Metastatic Gastric Cancer
Boxed warnings
- 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 anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.2 , 5.4) ]. Embryo-Fetal Toxicity Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1 , 8.3) ].
Common side effects
- Fatigue
- Infection
- Hot flashes
- Dyspnea
- Anemia
- Rash/desquamation
- Leukopenia
- Neutropenia
- Headache
- Pain
- Fever
- Nausea
Serious adverse events
- Asymptomatic cardiac dysfunction
- Cardiac failure
- Hypersensitivity
- Cardiac disorder
- Autoimmune thyroiditis
- Interstitial pneumonitis
- Pulmonary hypertension
- Ventricular disorder
- Sudden death
- Febrile neutropenia
Drug interactions
- Anthracyclines
Key clinical trials
- Phase Ib/II Trial of Copanlisib in Combination With Trastuzumab and Pertuzumab After Induction Treatment of HER2 Positive (HER2+) Metastatic Breast Cancer (MBC) With PIK3CA Mutation or PTEN Mutation (Phase 1)
- A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy (Phase 3)
- Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT) (EARLY/Phase 1)
- A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Pacl (Phase 3)
- MATCH Treatment Subprotocol J: Trastuzumab and Pertuzumab (HP) in Patients With Non-Breast, Non-Gastric/GEJ, and Non-Colorectal Cancers With HER2 Amplification (Phase 2)
- A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With M (Phase 1)
- Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction: A Randomized, Controlled Trial (Phase 2)
- HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Loc (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- KANJINTI CI brief — competitive landscape report
- KANJINTI updates RSS · CI watch RSS
- AMGEN INC portfolio CI
Frequently asked questions about KANJINTI
What is KANJINTI?
KANJINTI (TRASTUZUMAB-ANNS) is a HER2/neu Receptor Antagonist [EPC] drug developed by AMGEN INC, indicated for Adjuvant Breast Cancer, Metastatic Breast Cancer - First Line, Metastatic Breast Cancer - Subsequent Therapy.
What is KANJINTI used for?
KANJINTI is indicated for Adjuvant Breast Cancer, Metastatic Breast Cancer - First Line, Metastatic Breast Cancer - Subsequent Therapy, Metastatic Gastric Cancer.
Who makes KANJINTI?
KANJINTI is developed and marketed by AMGEN INC (see full AMGEN INC pipeline at /company/amgen).
What is the generic name of KANJINTI?
TRASTUZUMAB-ANNS is the generic (nonproprietary) name of KANJINTI.
What drug class is KANJINTI in?
KANJINTI belongs to the HER2/neu Receptor Antagonist [EPC] class. See all HER2/neu Receptor Antagonist [EPC] drugs at /class/her2-neu-receptor-antagonist-epc.
What development phase is KANJINTI in?
KANJINTI is FDA-approved (marketed).
What are the side effects of KANJINTI?
Common side effects of KANJINTI include Fatigue, Infection, Hot flashes, Dyspnea, Anemia, Rash/desquamation. Serious adverse events: Asymptomatic cardiac dysfunction, Cardiac failure, Hypersensitivity, Cardiac disorder.
Related
- Drug class: All HER2/neu Receptor Antagonist [EPC] drugs
- Manufacturer: AMGEN INC — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Adjuvant Breast Cancer
- Indication: Drugs for Metastatic Breast Cancer - First Line
- Indication: Drugs for Metastatic Breast Cancer - Subsequent Therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing