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Herceptin Hylecta®
Herceptin Hylecta® is a HER2-targeted monoclonal antibody Biologic drug developed by Biocon Biologics UK PLC. It is currently FDA-approved for HER2-positive early breast cancer (adjuvant and neoadjuvant treatment), HER2-positive metastatic breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Herceptin Hylecta is a subcutaneous formulation of trastuzumab that binds to HER2 receptors on cancer cells to block growth signaling and trigger immune-mediated cell death.
Herceptin Hylecta is a subcutaneous formulation of trastuzumab that binds to HER2 receptors on cancer cells to block growth signaling and trigger immune-mediated cell death. Used for HER2-positive early breast cancer (adjuvant and neoadjuvant treatment), HER2-positive metastatic breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma.
At a glance
| Generic name | Herceptin Hylecta® |
|---|---|
| Sponsor | Biocon Biologics UK PLC |
| Drug class | HER2-targeted monoclonal antibody |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Trastuzumab is a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2), which is overexpressed in certain breast and gastric cancers. By binding to HER2, it prevents ligand-independent signaling and recruits immune cells to destroy cancer cells through antibody-dependent cellular cytotoxicity (ADCC). Hylecta is a subcutaneous formulation designed to improve patient convenience compared to intravenous administration.
Approved indications
- HER2-positive early breast cancer (adjuvant and neoadjuvant treatment)
- HER2-positive metastatic breast cancer
- HER2-positive gastric or gastroesophageal junction adenocarcinoma
Common side effects
- Infusion-related reactions
- Cardiotoxicity/left ventricular dysfunction
- Neuropathy
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (PHASE2)
- A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers (PHASE1)
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:
- Herceptin Hylecta® CI brief — competitive landscape report
- Herceptin Hylecta® updates RSS · CI watch RSS
- Biocon Biologics UK PLC portfolio CI
Frequently asked questions about Herceptin Hylecta®
What is Herceptin Hylecta®?
How does Herceptin Hylecta® work?
What is Herceptin Hylecta® used for?
Who makes Herceptin Hylecta®?
What drug class is Herceptin Hylecta® in?
What development phase is Herceptin Hylecta® in?
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What does Herceptin Hylecta® target?
Related
- Drug class: All HER2-targeted monoclonal antibody drugs
- Target: All drugs targeting HER2 (human epidermal growth factor receptor 2)
- Manufacturer: Biocon Biologics UK PLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for HER2-positive early breast cancer (adjuvant and neoadjuvant treatment)
- Indication: Drugs for HER2-positive metastatic breast cancer
- Indication: Drugs for HER2-positive gastric or gastroesophageal junction adenocarcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing