HERZUMA
HERZUMA is a HER2/neu receptor antagonist indicated for the treatment of adults with HER2-overexpressing breast cancer or metastatic gastric and gastroesophageal junction adenocarcinoma. In the adjuvant breast cancer setting, it is used as part of various multi-drug regimens or as a single agent following anthracycline-based therapy. For metastatic disease, the drug is administered as a first-line treatment in combination with other therapies or as a single agent for patients who have already received one or more chemotherapy regimens.
How HERZUMA Works
HERZUMA targets the HER2 transmembrane receptor protein, which is a product of the HER2 proto-oncogene. The drug binds to these receptors to inhibit the proliferation of human tumor cells that overexpress HER2. Additionally, it functions as a mediator of antibody-dependent cellular cytotoxicity, which preferentially targets and destroys cancer cells that overexpress the HER2 receptor.
Details
- Status
- Prescription
- First Approved
- 2018-12-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HERZUMA Approval History
What HERZUMA Treats
3 indicationsHERZUMA is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
HERZUMA 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 HERZUMA for cardiomyopathy. ( 2.5 , 5.1 ) Infusion Reactions, Pulmonary Toxicity: Discontinue HERZUMA 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 HERZUMA. Discontinue HERZUMA treatment in patients receiving adjuvant therapy and withhold HERZUMA 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 HERZUMA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue HERZUMA for anaphyla
HERZUMA 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.
HERZUMA is a lower-cost alternative to Herceptin with no clinically meaningful differences. Requires prescriber approval to substitute.
HERZUMA Competitors
Pro10 other drugs also target HER2. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (HER2). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to HERZUMA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
HERZUMA FDA Label Details
ProIndications & Usage
FDA Label (PDF)HERZUMA is a HER2/neu receptor antagonist indicated in adults for: the treatment of HER2-overexpressing breast cancer. the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. 1.1 Adjuvant Breast Cancer HERZUMA is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, ...
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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.