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Maintenance chemotherapy 1
Maintenance chemotherapy 1 is a Small molecule drug developed by Shanghai Proton and Heavy Ion Center. It is currently in Phase 3 development for Cancer maintenance therapy (specific indication dependent on primary malignancy and induction regimen).
Maintenance chemotherapy 1 refers to a continuation of cytotoxic chemotherapy after initial induction treatment to sustain disease control and improve long-term outcomes.
Maintenance chemotherapy 1 refers to a continuation of cytotoxic chemotherapy after initial induction treatment to sustain disease control and improve long-term outcomes. Used for Cancer maintenance therapy (specific indication dependent on primary malignancy and induction regimen).
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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 | Maintenance chemotherapy 1 |
|---|---|
| Sponsor | Shanghai Proton and Heavy Ion Center |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Maintenance chemotherapy involves administering lower doses or intermittent cycles of chemotherapeutic agents following completion of primary induction therapy. This approach aims to eliminate residual disease, delay recurrence, and prolong progression-free and overall survival. The specific mechanism depends on the chemotherapy agents used, which typically target rapidly dividing cancer cells through DNA damage or mitotic inhibition.
Approved indications
- Cancer maintenance therapy (specific indication dependent on primary malignancy and induction regimen)
Common side effects
- Myelosuppression
- Nausea and vomiting
- Fatigue
- Infection risk
- Mucositis
Key clinical trials
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50% (PHASE2)
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma (PHASE2, PHASE3)
- A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL) (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:
- Maintenance chemotherapy 1 CI brief — competitive landscape report
- Maintenance chemotherapy 1 updates RSS · CI watch RSS
- Shanghai Proton and Heavy Ion Center portfolio CI
Frequently asked questions about Maintenance chemotherapy 1
What is Maintenance chemotherapy 1?
How does Maintenance chemotherapy 1 work?
What is Maintenance chemotherapy 1 used for?
Who makes Maintenance chemotherapy 1?
What development phase is Maintenance chemotherapy 1 in?
What are the side effects of Maintenance chemotherapy 1?
Related
- Manufacturer: Shanghai Proton and Heavy Ion Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Cancer maintenance therapy (specific indication dependent on primary malignancy and induction regimen)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing