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MYL-1401H
MYL-1401H is a biosimilar of trastuzumab that binds to HER2 receptors on cancer cells to inhibit their growth and promote immune-mediated cell death.
MYL-1401H is a biosimilar of trastuzumab that binds to HER2 receptors on cancer cells to inhibit their growth and promote immune-mediated cell death. Used for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting), HER2-positive metastatic gastric cancer.
At a glance
| Generic name | MYL-1401H |
|---|---|
| Also known as | Recombinant human granulocyte colony-stimulating factor (G-CSF), Pegfilgrastim |
| Sponsor | Mylan Inc. |
| Drug class | HER2-targeted monoclonal antibody (trastuzumab biosimilar) |
| Target | HER2 (human epidermal growth factor receptor 2) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
As a trastuzumab biosimilar, MYL-1401H is a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2) expressed on cancer cells. By binding to HER2, it blocks growth signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)
- HER2-positive metastatic gastric cancer
Common side effects
- Cardiotoxicity / left ventricular dysfunction
- Infusion-related reactions
- Nausea and vomiting
- Diarrhea
- Fatigue
- Headache
Key clinical trials
- Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta (PHASE1)
- Efficacy and Safety Study With MYL-1401H and Neulasta (PHASE3)
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 |