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FOLFIRI + bevacizumab
FOLFIRI + bevacizumab is a Chemotherapy + monoclonal antibody (anti-VEGF) Small molecule drug developed by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). It is currently in Phase 3 development for Metastatic colorectal cancer, Advanced colorectal cancer.
FOLFIRI + bevacizumab combines chemotherapy with an anti-angiogenic monoclonal antibody to kill cancer cells and block tumor blood vessel formation.
FOLFIRI + bevacizumab is a chemotherapy regimen used to treat various conditions, including metastatic colorectal cancer, unresectable colon cancer peritoneal metastases, and peritoneal carcinosis. Bevacizumab is a vascular endothelial growth factor A inhibitor, an antibody that targets and inhibits the growth of new blood vessels that tumors need to grow.
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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 | FOLFIRI + bevacizumab |
|---|---|
| Sponsor | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) |
| Drug class | Chemotherapy + monoclonal antibody (anti-VEGF) |
| Target | VEGF (bevacizumab component); topoisomerase I and thymidylate synthase (FOLFIRI components) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FOLFIRI is a chemotherapy regimen (fluorouracil, leucovorin, and irinotecan) that damages DNA and inhibits cell division. Bevacizumab is a monoclonal antibody targeting vascular endothelial growth factor (VEGF), which prevents new blood vessel formation that tumors depend on for growth and metastasis. Together, they provide dual mechanisms: direct cytotoxic chemotherapy and anti-angiogenic activity.
Approved indications
- Metastatic colorectal cancer
- Advanced colorectal cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Fatigue
- Hypertension
- Bleeding/hemorrhage
- Thrombosis
- Hand-foot skin reaction
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (PHASE2, PHASE3)
- Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (PHASE3)
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
- A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers (PHASE1)
- EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer (EARLY_PHASE1)
- Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66) (PHASE3)
- FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer (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:
- FOLFIRI + bevacizumab CI brief — competitive landscape report
- FOLFIRI + bevacizumab updates RSS · CI watch RSS
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) portfolio CI
Frequently asked questions about FOLFIRI + bevacizumab
What is FOLFIRI + bevacizumab?
How does FOLFIRI + bevacizumab work?
What is FOLFIRI + bevacizumab used for?
Who makes FOLFIRI + bevacizumab?
What drug class is FOLFIRI + bevacizumab in?
What development phase is FOLFIRI + bevacizumab in?
What are the side effects of FOLFIRI + bevacizumab?
What does FOLFIRI + bevacizumab target?
Related
- Drug class: All Chemotherapy + monoclonal antibody (anti-VEGF) drugs
- Target: All drugs targeting VEGF (bevacizumab component); topoisomerase I and thymidylate synthase (FOLFIRI components)
- Manufacturer: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Advanced colorectal cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing