Last reviewed 2026-05-28 · How we verify

Platinum + Gemcitabine

Platinum + Gemcitabine is a Chemotherapy combination (platinum agent + nucleoside analog) Small molecule drug developed by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. It is currently FDA-approved for Non-small cell lung cancer, Ovarian cancer, Bladder cancer.

Platinum compounds form DNA crosslinks while gemcitabine inhibits ribonucleotide reductase and DNA synthesis, together producing synergistic cytotoxic effects against cancer cells.

Platinum is a small molecule modality, and it is used in combination with Gemcitabine, a chemotherapeutic agent, to treat various types of cancer, including Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, and Non-Squamous Non-Small Cell Lung Cancer.

At a glance

Mechanism of action

Platinum agents (typically cisplatin or carboplatin) covalently bind to DNA, creating interstrand crosslinks that prevent replication and transcription. Gemcitabine is a nucleoside analog that inhibits ribonucleotide reductase, depleting deoxyribonucleotides and causing chain termination during DNA synthesis. The combination exploits complementary mechanisms to maximize tumor cell death while potentially reducing individual drug doses.

Approved indications

• Non-small cell lung cancer
• Ovarian cancer
• Bladder cancer
• Pancreatic cancer
• Breast cancer

Common side effects

• Myelosuppression (neutropenia, thrombocytopenia)
• Nausea and vomiting
• Nephrotoxicity
• Ototoxicity
• Peripheral neuropathy
• Anemia
• Fatigue
• 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.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Platinum + Gemcitabine CI brief — competitive landscape report
• Platinum + Gemcitabine updates RSS · CI watch RSS
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS portfolio CI

Frequently asked questions about Platinum + Gemcitabine

Related

• Drug class: All Chemotherapy combination (platinum agent + nucleoside analog) drugs
• Target: All drugs targeting DNA (platinum crosslinking); ribonucleotide reductase and DNA polymerase (gemcitabine)
• Manufacturer: Fondazione Policlinico Universitario Agostino Gemelli IRCCS — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Non-small cell lung cancer
• Indication: Drugs for Ovarian cancer
• Indication: Drugs for Bladder cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing