Last reviewed 2026-04-23 · How we verify

LV5FU2 or capectitabine

Federation Francophone de Cancerologie Digestive · Phase 3 active Small molecule

LV5FU2 or capectitabine is a Fluoropyrimidine antimetabolite Small molecule drug developed by Federation Francophone de Cancerologie Digestive. It is currently in Phase 3 development for Colorectal cancer (metastatic and adjuvant), Gastric cancer, Breast cancer.

LV5FU2 and capecitabine are fluoropyrimidine chemotherapy agents that inhibit thymidylate synthase and get incorporated into DNA/RNA to disrupt cancer cell replication.

LV5FU2 and capecitabine are fluoropyrimidine chemotherapy agents that inhibit thymidylate synthase and get incorporated into DNA/RNA to disrupt cancer cell replication. Used for Colorectal cancer (metastatic and adjuvant), Gastric cancer, Breast cancer.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	LV5FU2 or capectitabine
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

LV5FU2 is a regimen combining 5-fluorouracil (5-FU) with leucovorin (folinic acid), which enhances 5-FU's activity by stabilizing its binding to thymidylate synthase. Capecitabine is an oral prodrug of 5-FU that is metabolized preferentially in tumor tissue. Both agents ultimately block nucleotide synthesis and induce apoptosis in rapidly dividing cancer cells.

Approved indications

Colorectal cancer (metastatic and adjuvant)
Gastric cancer
Breast cancer

Common side effects

Hand-foot skin reaction (palmar-plantar erythrodysesthesia)
Diarrhea
Nausea and vomiting
Mucositis
Myelosuppression (neutropenia, thrombocytopenia)
Fatigue

Key clinical trials

Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over (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:

LV5FU2 or capectitabine CI brief — competitive landscape report
LV5FU2 or capectitabine updates RSS · CI watch RSS
Federation Francophone de Cancerologie Digestive portfolio CI

Frequently asked questions about LV5FU2 or capectitabine

What is LV5FU2 or capectitabine?

LV5FU2 or capectitabine is a Fluoropyrimidine antimetabolite drug developed by Federation Francophone de Cancerologie Digestive, indicated for Colorectal cancer (metastatic and adjuvant), Gastric cancer, Breast cancer.

How does LV5FU2 or capectitabine work?

LV5FU2 and capecitabine are fluoropyrimidine chemotherapy agents that inhibit thymidylate synthase and get incorporated into DNA/RNA to disrupt cancer cell replication.

What is LV5FU2 or capectitabine used for?

LV5FU2 or capectitabine is indicated for Colorectal cancer (metastatic and adjuvant), Gastric cancer, Breast cancer.

Who makes LV5FU2 or capectitabine?

LV5FU2 or capectitabine is developed by Federation Francophone de Cancerologie Digestive (see full Federation Francophone de Cancerologie Digestive pipeline at /company/federation-francophone-de-cancerologie-digestive).

What drug class is LV5FU2 or capectitabine in?

LV5FU2 or capectitabine belongs to the Fluoropyrimidine antimetabolite class. See all Fluoropyrimidine antimetabolite drugs at /class/fluoropyrimidine-antimetabolite.

What development phase is LV5FU2 or capectitabine in?

LV5FU2 or capectitabine is in Phase 3.

What are the side effects of LV5FU2 or capectitabine?

Common side effects of LV5FU2 or capectitabine include Hand-foot skin reaction (palmar-plantar erythrodysesthesia), Diarrhea, Nausea and vomiting, Mucositis, Myelosuppression (neutropenia, thrombocytopenia), Fatigue.

What does LV5FU2 or capectitabine target?

LV5FU2 or capectitabine targets Thymidylate synthase and is a Fluoropyrimidine antimetabolite.

Drug class: All Fluoropyrimidine antimetabolite drugs
Target: All drugs targeting Thymidylate synthase
Manufacturer: Federation Francophone de Cancerologie Digestive — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Colorectal cancer (metastatic and adjuvant)
Indication: Drugs for Gastric cancer
Indication: Drugs for Breast cancer

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