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long-course chemotherapy
long-course chemotherapy is a Chemotherapy Small molecule drug developed by Associazione Italiana per lo Studio del Pancreas. It is currently in Phase 3 development for Treatment of various cancers.
Long-course chemotherapy involves administering chemotherapy drugs over an extended period to target and kill cancer cells.
Researchers are studying a treatment for locally advanced rectal cancer that involves long-course chemotherapy combined with radiotherapy, with or without immunotherapy using the anti-PD-1 antibody drug Serplulimab. This treatment modality targets proteins, specifically WT1-331 long, which is a protein modality.
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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 | long-course chemotherapy |
|---|---|
| Sponsor | Associazione Italiana per lo Studio del Pancreas |
| Drug class | Chemotherapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This approach allows for higher doses of chemotherapy to be administered, increasing the likelihood of killing cancer cells while minimizing damage to healthy cells. However, it also increases the risk of side effects and toxicity.
Approved indications
- Treatment of various cancers
Common side effects
- Nausea
- Fatigue
- Hair loss
- Anemia
- Neutropenia
Key clinical trials
- The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders (NA)
- Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (PHASE3)
- Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC (PHASE2)
- Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors (PHASE2)
- Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION) (PHASE3)
- Digital CBT-I for Patients With Chronic Pain and Insomnia (NA)
- NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer (PHASE1)
- A Clinical Trial Comparing Long-Course Versus Short-Course Radiotherapy Followed by Immunotherapy Combined With Total Neoadjuvant Therapy (TNT) to Long-Course Radiotherapy Followed by TNT in High-Risk Locally Advanced Rectal Cancer (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:
- long-course chemotherapy CI brief — competitive landscape report
- long-course chemotherapy updates RSS · CI watch RSS
- Associazione Italiana per lo Studio del Pancreas portfolio CI
Frequently asked questions about long-course chemotherapy
What is long-course chemotherapy?
How does long-course chemotherapy work?
What is long-course chemotherapy used for?
Who makes long-course chemotherapy?
What drug class is long-course chemotherapy in?
What development phase is long-course chemotherapy in?
What are the side effects of long-course chemotherapy?
Related
- Drug class: All Chemotherapy drugs
- Manufacturer: Associazione Italiana per lo Studio del Pancreas — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Treatment of various cancers
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing