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Cisplatin + Gemcitabine
Cisplatin + Gemcitabine is a Chemotherapy combination (platinum agent + nucleoside analog) Small molecule drug developed by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It is currently in Phase 3 development for Advanced or metastatic urothelial carcinoma, Non-small cell lung cancer, Pancreatic cancer. Also known as: Cisplatin and Gemcitabine for 6 cyles followed by Best supportive care..
Cisplatin and gemcitabine work together as a chemotherapy combination to damage cancer cell DNA and inhibit nucleotide synthesis, leading to cell death.
Cisplatin and Gemcitabine are small molecule chemotherapeutic agents used to treat various conditions, including lung cancer, lung cancer stages II and III, advanced solid tumors, and biliary tract carcinoma. The combination of Cisplatin and Gemcitabine is used in chemotherapy regimens, often in combination with other agents, to target cancer 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 | Cisplatin + Gemcitabine |
|---|---|
| Also known as | Cisplatin and Gemcitabine for 6 cyles followed by Best supportive care. |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Drug class | Chemotherapy combination (platinum agent + nucleoside analog) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cisplatin is a platinum-based alkylating agent that forms DNA cross-links, preventing replication and transcription. Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, disrupting synthesis. Together, they provide synergistic cytotoxic effects against rapidly dividing cancer cells.
Approved indications
- Advanced or metastatic urothelial carcinoma
- Non-small cell lung cancer
- Pancreatic cancer
- Ovarian cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Nausea and vomiting
- Nephrotoxicity
- Ototoxicity
- Peripheral neuropathy
- Anemia
- Alopecia
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:
- Cisplatin + Gemcitabine CI brief — competitive landscape report
- Cisplatin + Gemcitabine updates RSS · CI watch RSS
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins portfolio CI
Frequently asked questions about Cisplatin + Gemcitabine
What is Cisplatin + Gemcitabine?
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Related
- Drug class: All Chemotherapy combination (platinum agent + nucleoside analog) drugs
- Manufacturer: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic urothelial carcinoma
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Pancreatic cancer
- Also known as: Cisplatin and Gemcitabine for 6 cyles followed by Best supportive care.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing