Last reviewed · How we verify
ASP2215
ASP2215 is a selective and potent inhibitor of the anaplastic lymphoma kinase (ALK) receptor tyrosine kinase.
ASP2215 is a selective and potent inhibitor of the anaplastic lymphoma kinase (ALK) receptor tyrosine kinase. Used for Non-small cell lung cancer with ALK rearrangement, Ceritinib-resistant non-small cell lung cancer with ALK rearrangement.
At a glance
| Generic name | ASP2215 |
|---|---|
| Also known as | gilteritinib |
| Sponsor | Astellas Pharma Global Development, Inc. |
| Drug class | ALK inhibitor |
| Target | ALK |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
ALK is a protein that, when mutated or overexpressed, can contribute to the development and progression of certain cancers. ASP2215 works by blocking the activity of the ALK protein, which can help slow or stop the growth of cancer cells.
Approved indications
- Non-small cell lung cancer with ALK rearrangement
- Ceritinib-resistant non-small cell lung cancer with ALK rearrangement
Common side effects
- Neutropenia
- Diarrhea
- Vomiting
- Fatigue
- Nausea
Key clinical trials
- Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) (PHASE1)
- VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML (PHASE3)
- A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) (PHASE1, PHASE2)
- MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib (PHASE3)
- Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML (PHASE1, PHASE2)
- SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation (PHASE1)
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:
- ASP2215 CI brief — competitive landscape report
- ASP2215 updates RSS · CI watch RSS
- Astellas Pharma Global Development, Inc. portfolio CI