OnCo
drugsProductPhase 3

Bemarituzumab

Bemarituzumab is an antibody against FGFR2b, a growth receptor overproduced in about a third of stomach cancers. It improved survival early in its phase 3 trial, but the gain faded with longer follow-up.

Afucosylated IgG1 blocking FGFR2b ligand binding and enhancing ADCC. FORTITUDE-101: interim OS 17.9 vs 12.5 months (HR 0.61) in FGFR2b ≥10% 2+/3+ tumours, attenuated at updated analysis (ESMO 2025). Corneal adverse events are frequent. FORTITUDE-102 adds nivolumab. The regulatory path was still uncertain in September 2026.

Schematic of the modality · Monoclonal antibody (anti-FGFR2b) · not a molecule; see the Monoclonal antibodies page
Mechanism, step by step
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1.Bemarituzumab binds the FGFR2b receptor on tumour cells

Modality
Monoclonal antibody (anti-FGFR2b)
Mechanism
Blocks FGF ligand binding to FGFR2b and recruits NK-mediated ADCC.
Brand / code
FPA144
Where it is approved
USunder reviewEUUKJPCNunder reviewAUcompare regions →

Compare all products across the US, EU, UK, Japan, China and Australia →

Safety

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Toxicity profile
Adverse event
Corneal adverse events (keratitis, dry eye)
Stomatitis

Frequent; dose-limiting. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
12 studies1 recruiting10 Phase 22 Phase 3
Search “Bemarituzumab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Bemarituzumab
intervention: Bemarituzumab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

FORTITUDE-101

Latest papers

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Literature trend4 papers in the last 12 months-33% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Bemarituzumab" OR ABSTRACT:"Bemarituzumab" OR TITLE:"FPA144" OR ABSTRACT:"FPA144") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Bemarituzumab, not a curated reading list.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Gastric & gastro-oesophageal junction cancer

technologies

1
Monoclonal antibodies

targets

1
FGFR2

companies

1
Amgen

pathways

1
RAS / RAF / MEK / ERK (MAPK)

trials

1
FORTITUDE-101