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Ifosfamide, Gemcitabine
Ifosfamide, Gemcitabine is a Chemotherapy combination (alkylating agent + nucleoside analog) Small molecule drug developed by European Lung Cancer Working Party. It is currently in Phase 3 development for Lung cancer (phase 3 trial setting).
This combination of ifosfamide and gemcitabine uses two chemotherapy agents that damage DNA and inhibit nucleotide synthesis to kill rapidly dividing cancer cells.
This combination of ifosfamide and gemcitabine uses two chemotherapy agents that damage DNA and inhibit nucleotide synthesis to kill rapidly dividing cancer cells. Used for Lung cancer (phase 3 trial setting).
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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 | Ifosfamide, Gemcitabine |
|---|---|
| Sponsor | European Lung Cancer Working Party |
| Drug class | Chemotherapy combination (alkylating agent + nucleoside analog) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Ifosfamide is an alkylating agent that cross-links DNA strands, preventing replication and transcription. Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination. Together, they provide complementary cytotoxic mechanisms targeting cancer cell proliferation.
Approved indications
- Lung cancer (phase 3 trial setting)
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Nausea and vomiting
- Alopecia
- Hemorrhagic cystitis (ifosfamide-related)
- Nephrotoxicity
- Neurotoxicity
Key clinical trials
- Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia (PHASE2)
- Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (PHASE1, PHASE2)
- Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma (PHASE3)
- A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma (PHASE3)
- Modified R-MINE Regimen vs. R-GemOx Regimens on the Treatment of Late Relapsed DLBCL (NA)
- A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma (PHASE1, PHASE2)
- Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma (PHASE3)
- Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI (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:
- Ifosfamide, Gemcitabine CI brief — competitive landscape report
- Ifosfamide, Gemcitabine updates RSS · CI watch RSS
- European Lung Cancer Working Party portfolio CI
Frequently asked questions about Ifosfamide, Gemcitabine
What is Ifosfamide, Gemcitabine?
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Related
- Drug class: All Chemotherapy combination (alkylating agent + nucleoside analog) drugs
- Manufacturer: European Lung Cancer Working Party — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Lung cancer (phase 3 trial setting)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing