TRAZIMERA
TRAZIMERA (trastuzumab-qyyp) is a HER2/neu receptor antagonist indicated for the treatment of adults with HER2-overexpressing breast cancer and metastatic gastric or 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 either in combination with chemotherapy or as a single agent depending on the specific cancer type and prior treatment history. Patient selection for all indications requires the use of an FDA-approved companion diagnostic to confirm HER2 overexpression.
How TRAZIMERA Works
TRAZIMERA targets the HER2 (or c-erbB2) proto-oncogene, which encodes a 185 kDa transmembrane receptor protein structurally related to the epidermal growth factor receptor. By binding to this receptor, the drug inhibits the proliferation of human tumor cells that overexpress HER2. Additionally, it acts as a mediator of antibody-dependent cellular cytotoxicity (ADCC). This immune-mediated response is preferentially exerted on cancer cells that overexpress HER2 compared to those that do not.
Details
- Status
- Prescription
- First Approved
- 2019-03-11
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRAZIMERA Approval History
What TRAZIMERA Treats
3 indicationsTRAZIMERA 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
TRAZIMERA 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 TRAZIMERA for cardiomyopathy. ( 2.5 , 5.1 ) Infusion Reactions, Pulmonary Toxicity: Discontinue TRAZIMERA 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 TRAZIMERA. Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA 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 TRAZIMERA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue TRAZIMERA
TRAZIMERA 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.
TRAZIMERA is a lower-cost alternative to Herceptin with no clinically meaningful differences. Requires prescriber approval to substitute.
TRAZIMERA 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 TRAZIMERA
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.
TRAZIMERA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRAZIMERA 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 TRAZIMERA 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 dox...
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.