Overview
Gilteritinib, also known as ASP2215, is a small molecule part of the FLT3 tyrosine kinase inhibitors that presented a greater selectivity and potency when compared with other agents from this group. It is a pyrazinecarboxamide derivative that showed high selectivity to FLT3 preventing the c-Kit -driven myelosuppression observed in other therapies. Gilteritinib was developed by Astellas Pharma and FDA approved on November 28, 2018. This drug was approved after being designed as an orphan drug with a fast track and priority review status.
Background
Gilteritinib, also known as ASP2215, is a small molecule part of the FLT3 tyrosine kinase inhibitors that presented a greater selectivity and potency when compared with other agents from this group. It is a pyrazinecarboxamide derivative that showed high selectivity to FLT3 preventing the c-Kit -driven myelosuppression observed in other therapies. Gilteritinib was developed by Astellas Pharma and FDA approved on November 28, 2018. This drug was approved after being designed as an orphan drug with a fast track and priority review status.
Indication
Gilteritinib is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation detected by an FDA-approved test. This indication was expanded for a companion diagnostic to include use with gilteritinib such as the LeukoStrat CDx FLT3 Mutation Assay. Acute myeloid leukemia is cancer that impacts the blood and bone marrow with a rapid progression. This condition produces low numbers of normal blood cells and the requirement of continuous need for transfusions.
Associated Conditions
- Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 2 | Not yet recruiting | |||
2025/05/28 | Not Applicable | Not yet recruiting | |||
2024/12/16 | N/A | Recruiting | |||
2024/11/20 | Phase 2 | Recruiting | |||
2024/10/31 | Phase 2 | Not yet recruiting | |||
2024/08/20 | Phase 1 | Recruiting | |||
2024/03/19 | Phase 2 | Recruiting | |||
2024/02/01 | Phase 1 | Recruiting | |||
2024/01/26 | Phase 1 | Recruiting | |||
2024/01/24 | Phase 1 | Recruiting | Uma Borate |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Astellas Pharma US, Inc. | 0469-1425 | ORAL | 40 mg in 1 1 | 1/1/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/24/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| XOSPATA® FILM-COATED TABLETS 40MG | SIN16088P | TABLET, FILM COATED | 40mg | 1/28/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Gilteritinib Fumarate Tablets | 国药准字HJ20210009 | 化学药品 | 片剂 | 1/30/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XOSPATA gilteritinib (as fumarate) 40 mg film-coated tablet blister pack | 321060 | Medicine | A | 4/2/2020 |