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Gemcitabine monotherapy
Gemcitabine monotherapy is a Nucleoside analog; antimetabolite Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Metastatic pancreatic cancer, Non-small cell lung cancer, Bladder cancer. Also known as: Background Gemcitabine-based Chemotherapy Regimen, GEMXAR.
Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, causing chain termination and cell death.
Gemcitabine is a small molecule used as a monotherapy for various conditions, including advanced solid tumors, nasopharyngeal carcinoma, non-muscle invasive bladder cancer, and carcinoma in situ of the bladder. It is administered as a treatment for these conditions, although the specific indications and dosing regimens may vary depending on the clinical trial or study.
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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. -
Big-pharma sponsor
+3.0pp
AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 monotherapy |
|---|---|
| Also known as | Background Gemcitabine-based Chemotherapy Regimen, GEMXAR |
| Sponsor | AstraZeneca |
| Drug class | Nucleoside analog; antimetabolite |
| Target | Ribonucleotide reductase; DNA incorporation |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Gemcitabine is a deoxycytidine analog that is phosphorylated intracellularly to its active triphosphate form. It inhibits ribonucleotide reductase, reducing deoxyribonucleotide pools, and is incorporated into DNA where it causes chain termination and apoptosis. It is particularly effective against rapidly dividing cancer cells.
Approved indications
- Metastatic pancreatic cancer
- Non-small cell lung cancer
- Bladder cancer
- Breast cancer
- Ovarian cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Fatigue
- Fever
- Rash
- Dyspnea
- Hemolytic uremic syndrome
Key clinical trials
- 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)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (PHASE3)
- MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (PHASE2)
- A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (PHASE3)
- Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (PHASE2)
- Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (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 monotherapy CI brief — competitive landscape report
- Gemcitabine monotherapy updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Gemcitabine monotherapy
What is Gemcitabine monotherapy?
How does Gemcitabine monotherapy work?
What is Gemcitabine monotherapy used for?
Who makes Gemcitabine monotherapy?
Is Gemcitabine monotherapy also known as anything else?
What drug class is Gemcitabine monotherapy in?
What development phase is Gemcitabine monotherapy in?
What are the side effects of Gemcitabine monotherapy?
What does Gemcitabine monotherapy target?
Related
- Drug class: All Nucleoside analog; antimetabolite drugs
- Target: All drugs targeting Ribonucleotide reductase; DNA incorporation
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic pancreatic cancer
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Bladder cancer
- Also known as: Background Gemcitabine-based Chemotherapy Regimen, GEMXAR
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing