Last reviewed · How we verify
Falimarev
Falimarev is a Biologic drug developed by National Cancer Institute (NCI). It is currently in Phase 2 development. Also known as: fCEA-MUC-1-TRI, Fowlpox-CEA(D609)-MUC1(L93)-TRICOM Vaccine, Fowlpox-CEA-MUC-1-TRICOM, PANVAC-F.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Falimarev |
|---|---|
| Also known as | fCEA-MUC-1-TRI, Fowlpox-CEA(D609)-MUC1(L93)-TRICOM Vaccine, Fowlpox-CEA-MUC-1-TRICOM, PANVAC-F, recombinant fowlpox-CEA-MUC-1-TRICOM vaccine |
| Sponsor | National Cancer Institute (NCI) |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (PHASE1)
- Study of Bacillus Calmette-Guerin (BCG) Combined With PANVAC Versus BCG Alone in Adults With High Grade Non-Muscle Invasive Bladder Cancer Who Failed At Least 1 Course of BCG (PHASE2)
- PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer (PHASE1, PHASE2)
- Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer (PHASE2)
- Docetaxel Alone or in Combination With Vaccine to Treat Breast 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:
- Falimarev CI brief — competitive landscape report
- Falimarev updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI
Frequently asked questions about Falimarev
What is Falimarev?
Who makes Falimarev?
Is Falimarev also known as anything else?
What development phase is Falimarev in?
Related
- Manufacturer: National Cancer Institute (NCI) — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: fCEA-MUC-1-TRI, Fowlpox-CEA(D609)-MUC1(L93)-TRICOM Vaccine, Fowlpox-CEA-MUC-1-TRICOM, PANVAC-F, recombinant fowlpox-CEA-MUC-1-TRICOM vaccine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing