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FPA144
FPA144 is a FGFR2b inhibitor monoclonal antibody Small molecule drug developed by Amgen. It is currently in Phase 2 development for Gastric cancer and gastroesophageal junction cancer with FGFR2b overexpression. Also known as: Bemarituzumab.
FPA144 is a monoclonal antibody that blocks fibroblast growth factor receptor 2b (FGFR2b) to inhibit tumor growth and angiogenesis.
Bemarituzumab, also known as FPA144, is an antibody that targets and inhibits fibroblast growth factor receptor 2. It is being studied in clinical trials for various types of cancer, including gastric cancer, recurrent bladder cancer, and advanced solid tumors.
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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). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies. -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | FPA144 |
|---|---|
| Also known as | Bemarituzumab |
| Sponsor | Amgen |
| Drug class | FGFR2b inhibitor monoclonal antibody |
| Target | FGFR2b (Fibroblast Growth Factor Receptor 2b) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
FPA144 selectively targets FGFR2b, a receptor involved in fibroblast growth factor signaling that promotes tumor cell proliferation and survival in certain cancers. By blocking this pathway, the drug aims to reduce tumor growth and inhibit the formation of new blood vessels that feed tumors. This mechanism is particularly relevant in gastric and gastroesophageal junction cancers that express high levels of FGFR2b.
Approved indications
- Gastric cancer and gastroesophageal junction cancer with FGFR2b overexpression
Common side effects
- Hyperphosphatemia
- Fatigue
- Nausea
- Diarrhea
- Decreased appetite
Key clinical trials
- Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (PHASE1)
- A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (PHASE2)
- A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (PHASE1)
- A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer (PHASE1)
- An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer
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:
- FPA144 CI brief — competitive landscape report
- FPA144 updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about FPA144
What is FPA144?
How does FPA144 work?
What is FPA144 used for?
Who makes FPA144?
Is FPA144 also known as anything else?
What drug class is FPA144 in?
What development phase is FPA144 in?
What are the side effects of FPA144?
What does FPA144 target?
Related
- Drug class: All FGFR2b inhibitor monoclonal antibody drugs
- Target: All drugs targeting FGFR2b (Fibroblast Growth Factor Receptor 2b)
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Gastric cancer and gastroesophageal junction cancer with FGFR2b overexpression
- Also known as: Bemarituzumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing