Floatz Rating
CCC52/100
Confidence
Indicative
Sponsor
Astellas Pharma Global Development, Inc.
Modality
Small molecule
Development Phase
Phase 1/2
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
40Moderate confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07140016CT.gov A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) | — | Recruiting | — | — | — |
NCT06225427CT.gov Gilteritinib for the Treatment of ALK NSCLC | — | Recruiting | — | — | — |
NCT02495233CT.gov A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) | — | Terminated | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
89High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Non-Small Cell Lung Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Gilteritinib (this asset) | Astellas Pharma Global Development, Inc. | P1/2 | CCC · 52 |
| Icotinib | The First Affiliated Hospital of Guangzhou Medical University | P4 | BBB |
| Necitumumab | Jonsson Comprehensive Cancer Center | P3 | BBB |
| Endostatin | Henan Cancer Hospital | P4 | BBB |
| Zorifertinib | Alpha Biopharma (Jiangsu) Co., Ltd. | P2/3 | BBB |
| d-0316 | Betta Pharmaceuticals Co., Ltd. | P2/3 | BBB |
| Glumetinib | Shanghai JMT-Bio Inc. | P3 | BBB |
| Onartuzumab | Hoffmann-La Roche | P3 | BBB |
| Vinorelbine Ditartrate | Intergroupe Francophone de Cancerologie Thoracique | P4 | BB |
+42 more in the Non-Small Cell Lung Carcinoma cohort
Other indications for Gilteritinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Acute Myeloid Leukemia | — | P3 | BB · 66 |
| Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication | — | P3 | BB · 66 |
| Myelodysplastic Syndrome With Excess Blasts-2 | — | P3 | B · 62 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Gilteritinib in Non-Small Cell Lung Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 14, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/gilteritinib-non-small-cell-lung-carcinoma
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