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Adjuvant systemic chemotherapy
Adjuvant systemic chemotherapy is a Small molecule drug developed by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. It is currently in Phase 3 development for Adjuvant treatment of various solid tumors following primary surgical resection.
Adjuvant systemic chemotherapy uses cytotoxic drugs administered after primary cancer treatment to eliminate residual cancer cells and reduce recurrence risk.
Adjuvant systemic chemotherapy is used to treat various types of cancer, including breast cancer, peritoneal carcinomatosis, colorectal cancer metastatic, stage III ovarian cancer, and stage IV ovarian cancer. The exact mechanism of adjuvant systemic chemotherapy is unknown, but it is often administered in conjunction with other treatments such as radiation therapy.
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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 | Adjuvant systemic chemotherapy |
|---|---|
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Adjuvant chemotherapy is a treatment strategy rather than a single drug, involving the systemic administration of chemotherapeutic agents following surgery or primary treatment. The goal is to target micrometastatic disease and improve overall survival by reducing the risk of cancer recurrence. The specific mechanism depends on the chemotherapy regimen used, which may include alkylating agents, antimetabolites, or other cytotoxic compounds.
Approved indications
- Adjuvant treatment of various solid tumors following primary surgical resection
Common side effects
- Myelosuppression (neutropenia, anemia, thrombocytopenia)
- Nausea and vomiting
- Alopecia
- Mucositis
- Fatigue
- Peripheral neuropathy
- Cardiotoxicity (depending on agents used)
Key clinical trials
- HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer (EARLY_PHASE1)
- Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (PHASE3)
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not (PHASE3)
- Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer (NA)
- Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer (PHASE3)
- A Study of Surgery and Radiotherapy in People With Breast Cancer (PHASE2)
- De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer (PHASE2)
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:
- Adjuvant systemic chemotherapy CI brief — competitive landscape report
- Adjuvant systemic chemotherapy updates RSS · CI watch RSS
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences portfolio CI
Frequently asked questions about Adjuvant systemic chemotherapy
What is Adjuvant systemic chemotherapy?
How does Adjuvant systemic chemotherapy work?
What is Adjuvant systemic chemotherapy used for?
Who makes Adjuvant systemic chemotherapy?
What development phase is Adjuvant systemic chemotherapy in?
What are the side effects of Adjuvant systemic chemotherapy?
Related
- Manufacturer: Cancer Institute and Hospital, Chinese Academy of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Adjuvant treatment of various solid tumors following primary surgical resection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing