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Trastuzumab SC
Trastuzumab SC is a HER2/neu receptor antagonist Small molecule drug developed by Dana-Farber Cancer Institute. It is currently in Phase 3 development for Adjuvant treatment of HER2-positive breast cancer, Neoadjuvant treatment of HER2-positive breast cancer, Treatment of HER2-positive metastatic breast cancer. Also known as: Herceptin Hylecta, Herceptin-600 mg/5 mL, Herceptin, RO0452317.
Trastuzumab SC is a monoclonal antibody that targets the HER2/neu receptor, inhibiting cancer cell growth and proliferation.
Trastuzumab SC is an antibody used to treat various conditions, including inoperable, locally advanced or metastatic, ER-positive, and HER2-positive breast cancer. It is a biosimilar of the original Trastuzumab, with the same modality as an antibody.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Trastuzumab SC |
|---|---|
| Also known as | Herceptin Hylecta, Herceptin-600 mg/5 mL, Herceptin, RO0452317 |
| Sponsor | Dana-Farber Cancer Institute |
| Drug class | HER2/neu receptor antagonist |
| Target | HER2/neu |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Trastuzumab SC binds to the extracellular domain of the HER2/neu receptor, preventing dimerization and subsequent activation of downstream signaling pathways that promote cell growth and survival. This leads to inhibition of cancer cell growth and induction of apoptosis. Additionally, Trastuzumab SC can also induce antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), further contributing to its anti-tumor effects.
Approved indications
- Adjuvant treatment of HER2-positive breast cancer
- Neoadjuvant treatment of HER2-positive breast cancer
- Treatment of HER2-positive metastatic breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Headache
- Musculoskeletal pain
Key clinical trials
- Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma (PHASE3)
- 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 Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer (PHASE3)
- Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients (PHASE1)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
- RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive (PHASE2, 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trastuzumab SC CI brief — competitive landscape report
- Trastuzumab SC updates RSS · CI watch RSS
- Dana-Farber Cancer Institute portfolio CI
Frequently asked questions about Trastuzumab SC
What is Trastuzumab SC?
How does Trastuzumab SC work?
What is Trastuzumab SC used for?
Who makes Trastuzumab SC?
Is Trastuzumab SC also known as anything else?
What drug class is Trastuzumab SC in?
What development phase is Trastuzumab SC in?
What are the side effects of Trastuzumab SC?
What does Trastuzumab SC target?
Related
- Drug class: All HER2/neu receptor antagonist drugs
- Target: All drugs targeting HER2/neu
- Manufacturer: Dana-Farber Cancer Institute — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of HER2-positive breast cancer
- Indication: Drugs for Neoadjuvant treatment of HER2-positive breast cancer
- Indication: Drugs for Treatment of HER2-positive metastatic breast cancer
- Also known as: Herceptin Hylecta, Herceptin-600 mg/5 mL, Herceptin, RO0452317
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing