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LV5FU2 or capecitabine
LV5FU2/capecitabine is a fluoropyrimidine prodrug that inhibits thymidylate synthase and gets incorporated into DNA/RNA, disrupting cancer cell replication.
LV5FU2/capecitabine is a fluoropyrimidine prodrug that inhibits thymidylate synthase and gets incorporated into DNA/RNA, disrupting cancer cell replication. Used for Colorectal cancer (metastatic and adjuvant settings), Gastric cancer, Breast cancer.
At a glance
| Generic name | LV5FU2 or capecitabine |
|---|---|
| Sponsor | Federation Francophone de Cancerologie Digestive |
| Drug class | Fluoropyrimidine antimetabolite |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Capecitabine is an oral prodrug of 5-fluorouracil (5-FU) that is preferentially activated in tumor tissue by thymidine phosphorylase. Once activated, it inhibits thymidylate synthase, blocking dTMP synthesis and preventing DNA replication, while also incorporating into RNA to disrupt protein synthesis. LV5FU2 refers to the combination of leucovorin (folinic acid) with 5-FU, where leucovorin enhances 5-FU efficacy by stabilizing the thymidylate synthase-FdUMP complex.
Approved indications
- Colorectal cancer (metastatic and adjuvant settings)
- Gastric cancer
- Breast cancer
- Pancreatic cancer
Common side effects
- Hand-foot skin reaction (palmar-plantar erythrodysesthesia)
- Diarrhea
- Nausea and vomiting
- Fatigue
- Stomatitis
- Myelosuppression (neutropenia, thrombocytopenia)
- Elevated liver enzymes
Key clinical trials
- MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents (NA)
- QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters. (PHASE3)
- A Trial to Evaluate the Potential Benefit of Adjuvant Chemotherapy for Small Bowel Adenocarcinoma (PHASE3)
- Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan1 Levels (PHASE2)
- Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (PHASE2)
- De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer (PHASE2)
- Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over (PHASE3)
- Two Chemotherapy Regimens Plus or Minus Bevacizumab (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:
- LV5FU2 or capecitabine CI brief — competitive landscape report
- LV5FU2 or capecitabine updates RSS · CI watch RSS
- Federation Francophone de Cancerologie Digestive portfolio CI