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Gemcitabine + cisplatin
Gemcitabine + cisplatin is a Chemotherapy combination (nucleoside analog + platinum alkylating agent) Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Metastatic or locally advanced non-small cell lung cancer, Metastatic pancreatic cancer, Urothelial carcinoma. Also known as: Background Gemcitabine-based Chemotherapy Regimen, Gemzar, Platinum based Standard of Care Chemotherapy, GC.
Gemcitabine and cisplatin work synergistically as chemotherapy agents that damage DNA and inhibit cell replication, leading to cancer cell death.
Gemcitabine and cisplatin work synergistically as chemotherapy agents that damage DNA and inhibit cell replication, leading to cancer cell death. Used for Metastatic or locally advanced non-small cell lung cancer, Metastatic pancreatic cancer, Urothelial carcinoma.
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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 + cisplatin |
|---|---|
| Also known as | Background Gemcitabine-based Chemotherapy Regimen, Gemzar, Platinum based Standard of Care Chemotherapy, GC, GemCis |
| Sponsor | AstraZeneca |
| Drug class | Chemotherapy combination (nucleoside analog + platinum alkylating agent) |
| 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, causing chain termination and apoptosis. Cisplatin is a platinum-based alkylating agent that forms DNA cross-links, preventing replication and transcription. Together, they provide complementary cytotoxic mechanisms that enhance overall anti-tumor activity.
Approved indications
- Metastatic or locally advanced non-small cell lung cancer
- Metastatic pancreatic cancer
- Urothelial carcinoma
- Ovarian cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Fatigue
- Nephrotoxicity
- Neurotoxicity (peripheral neuropathy)
- Alopecia
- Mucositis
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer (PHASE1)
- Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma (PHASE2)
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- Durvalumab With Gemcitabine and Cisplatin for the Treatment of High-Risk Resectable Liver Cancer Before Surgery (PHASE2)
- Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer (PHASE2)
- A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) (PHASE2)
- MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma (PHASE2)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (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:
- Gemcitabine + cisplatin CI brief — competitive landscape report
- Gemcitabine + cisplatin updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Gemcitabine + cisplatin
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Related
- Drug class: All Chemotherapy combination (nucleoside analog + platinum alkylating agent) drugs
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic or locally advanced non-small cell lung cancer
- Indication: Drugs for Metastatic pancreatic cancer
- Indication: Drugs for Urothelial carcinoma
- Also known as: Background Gemcitabine-based Chemotherapy Regimen, Gemzar, Platinum based Standard of Care Chemotherapy, GC, GemCis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing