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Gemcitabine, Docetaxel
Gemcitabine, Docetaxel is a Chemotherapy combination (nucleoside analog + taxane) Small molecule drug developed by Central European Cooperative Oncology Group. It is currently in Phase 3 development for Non-small cell lung cancer, Breast cancer, Ovarian cancer.
Gemcitabine and docetaxel are chemotherapy agents that work synergistically to inhibit cancer cell division and induce apoptosis through distinct mechanisms.
Gemcitabine and docetaxel are chemotherapy agents that work synergistically to inhibit cancer cell division and induce apoptosis through distinct mechanisms. Used for Non-small cell lung cancer, Breast cancer, Ovarian cancer.
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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 | Gemcitabine, Docetaxel |
|---|---|
| Sponsor | Central European Cooperative Oncology Group |
| Drug class | Chemotherapy combination (nucleoside analog + taxane) |
| Target | DNA synthesis (gemcitabine); microtubule stabilization (docetaxel) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, disrupting replication and transcription. Docetaxel is a taxane that stabilizes microtubules and prevents their disassembly, blocking mitotic progression. Together, they provide complementary cytotoxic effects against rapidly dividing cancer cells.
Approved indications
- Non-small cell lung cancer
- Breast cancer
- Ovarian cancer
- Pancreatic cancer
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea/vomiting
- Fatigue
- Peripheral neuropathy
- Alopecia
- Mucositis
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma (PHASE1, PHASE2)
- Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer (PHASE3)
- Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer (PHASE2)
- A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer (PHASE2)
- A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer (PHASE3)
- Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076) (PHASE3)
- Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC (PHASE2)
- A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy (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:
- Gemcitabine, Docetaxel CI brief — competitive landscape report
- Gemcitabine, Docetaxel updates RSS · CI watch RSS
- Central European Cooperative Oncology Group portfolio CI
Frequently asked questions about Gemcitabine, Docetaxel
What is Gemcitabine, Docetaxel?
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What is Gemcitabine, Docetaxel used for?
Who makes Gemcitabine, Docetaxel?
What drug class is Gemcitabine, Docetaxel in?
What development phase is Gemcitabine, Docetaxel in?
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What does Gemcitabine, Docetaxel target?
Related
- Drug class: All Chemotherapy combination (nucleoside analog + taxane) drugs
- Target: All drugs targeting DNA synthesis (gemcitabine); microtubule stabilization (docetaxel)
- Manufacturer: Central European Cooperative Oncology Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Breast cancer
- Indication: Drugs for Ovarian cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing