HERCEPTIN HYLECTA
HERCEPTIN HYLECTA is a combination of trastuzumab and hyaluronidase indicated for the treatment of adults with HER2-overexpressing breast cancer. It is used as adjuvant therapy for node-positive or high-risk node-negative disease, either as part of a multi-drug chemotherapy regimen or as a single agent following anthracycline-based therapy. The drug is also indicated for metastatic breast cancer, both as a first-line treatment in combination with paclitaxel and as a single agent for patients who have previously received chemotherapy. Patient selection for this therapy must be confirmed using an FDA-approved companion diagnostic for trastuzumab.
How HERCEPTIN HYLECTA Works
Trastuzumab is a HER2/neu receptor antagonist that binds to the HER2 protein to inhibit the proliferation of human tumor cells. It also functions as a mediator of antibody-dependent cellular cytotoxicity, which preferentially targets cancer cells that overexpress HER2. The hyaluronidase component acts as an endoglycosidase that temporarily depolymerizes hyaluronan in the subcutaneous tissue. This increases the permeability of the tissue, which enhances the absorption rate of trastuzumab into the systemic circulation.
Details
- Status
- Prescription
- First Approved
- 2019-02-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
HERCEPTIN HYLECTA Approval History
What HERCEPTIN HYLECTA Treats
1 indicationsHERCEPTIN HYLECTA is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
HERCEPTIN HYLECTA Boxed Warning
CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA for cardiomyopathy....
WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA for cardiomyopathy. ( 2.4 , 5.1 ) Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome. ( 5.3 ) Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA 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. ( 5.2 , 8.1 , 8.3 ) Cardiomyopathy HERCEPTIN HYLECTA administration can result in sub - clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving HERCEPTIN HYLECTA with anthracycline - containing chemotherapy regimens. Evaluate left ventricular function in all patients prior to and during treatment with HERCEPTIN HYLECTA. Discontinue HERCEPTIN HYLECTA treatment in patients receiving adjuvant therapy and withhold HERCEPTIN HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ]. Pulmonary Toxicity HERCEPTIN HYLECTA administration can result in serious and fatal pulmonary toxicity. Symptoms usually occur during or within 24 hours of HERCEPTIN HYLECTA administration. Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions (5.3 , 5.5) ] . Monitor patients until symptoms completely resolve. Embryo-Fetal Tox
HERCEPTIN HYLECTA 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.
HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA
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.
HERCEPTIN HYLECTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)HERCEPTIN HYLECTA is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, indicated in adults for: The treatment of HER2-overexpressing breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab. 1.1 Adjuvant Breast Cancer HERCEPTIN HYLECTA is indicated for adjuvant treatment of adults with 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, cyclophosphamide, ...
WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for complete boxed warning. Cardiomyopathy: HERCEPTIN HYLECTA can result in subclinical and clinical cardiac failure manifest...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.