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PCV chemotherapy alone
PCV chemotherapy alone is a chemotherapy Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Acute lymphoblastic leukemia, Hodgkin lymphoma.
PCV chemotherapy involves the combination of three chemotherapy drugs: methotrexate, cyclophosphamide, and vincristine, which work together to kill rapidly dividing cancer cells.
PCV chemotherapy is used to treat conditions such as solid tumors, oligodendroglioma, low-grade oligodendroglioma, and anaplastic gliomas with 1p/19q codeletion. PCV chemotherapy works by acting as a granulocyte colony-stimulating factor receptor agonist, stimulating the production of white blood cells.
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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 | PCV chemotherapy alone |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | chemotherapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Methotrexate is an antifolate drug that inhibits dihydrofolate reductase, disrupting DNA synthesis and cell division. Cyclophosphamide is an alkylating agent that cross-links DNA, causing DNA damage and cell death. Vincristine is a vinca alkaloid that binds to tubulin, disrupting microtubule formation and preventing cell division.
Approved indications
- Acute lymphoblastic leukemia
- Hodgkin lymphoma
Common side effects
- Nausea
- Vomiting
- Fatigue
- Hair loss
- Infection
Key clinical trials
- Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (PHASE1)
- Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas
- A Randomized Trial of Delayed Radiotherapy in Patients Low-grade Oligodendrogliomas Requiring a Treatment Other Than Surgery (PHASE3)
- gliomasPCV Only in 1p/19q Codeleted Anaplastic Gliomas (PHASE3)
- Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI (PHASE1, PHASE2)
- Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma (PHASE2, PHASE3)
- Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy (PHASE3)
- Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV (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:
- PCV chemotherapy alone CI brief — competitive landscape report
- PCV chemotherapy alone updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about PCV chemotherapy alone
What is PCV chemotherapy alone?
How does PCV chemotherapy alone work?
What is PCV chemotherapy alone used for?
Who makes PCV chemotherapy alone?
What drug class is PCV chemotherapy alone in?
What development phase is PCV chemotherapy alone in?
What are the side effects of PCV chemotherapy alone?
Related
- Drug class: All chemotherapy drugs
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute lymphoblastic leukemia
- Indication: Drugs for Hodgkin lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing