Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 40 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- To treat refractory or relapsed acute myeloid leukemia in adults with a FLT3 mutation as detected by an FDA-approved test.
Summary
- Gilteritinib (Xospata) is indicated for the treatment of refractory or relapsed acute myeloid leukemia in adults with a FLT3 mutation as detected by an FDA-approved test.
- Three systematic reviews/meta-analyses were reviewed to gather information about gilteritinib's effectiveness and safety profile.
- In patients with de novo relapsed and/or refractory acute myeloid leukemia who are not eligible for intensive chemotherapy, gilteritinib has shown promising results, providing median survival months of 9.3 compared to other therapies such as gemtuzumab ozogamicin (13.8 months), low-dose cytarabine (5.6 months), and best supportive care (3.2 months).
- A study found that FMS-like tyrosine kinase 3 inhibitors like gilteritinib improved complete remission rates in untreated Acute Myeloid Leukemia patients when compared to non-FLT3i treatments; this was also observed in cases of refractory and relapsed FLT+ AML where it significantly improved overall survival rates.
- Given its generally well-tolerated nature, there is potential for using these drugs alone or combined even among unfit AML patients; however, combinations with other antileukemic agents seem necessary due to the polyclonal nature of AML disease.
- While effective, use of gilteritinib may come with increased risk factors including thrombocytopenia, neutropenia, anemia skin-related adverse effects cardiac-related adverse effects increased alanine aminotransferase levels coughing dyspnea.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xospata (gliteritinib) Prescribing Information. | 2022 | Astellas Pharma US, Inc, Northbrook, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy of non-intensive therapies approved for relapsed/refractory acute myeloid leukemia: a systematic literature review. | 2022 | Future Oncology |
| Emerging FLT3 inhibitors for the treatment of acute myeloid leukemia. | 2022 | Expert opinion on emerging drugs |
| Clinical Benefits and Safety of FMS-Like Tyrosine Kinase 3 Inhibitors in Various Treatment Stages of Acute Myeloid Leukemia: A Systematic Review, Meta-Analysis, and Network Meta-Analysis. | 2021 | Frontiers in Oncology |
| Final clinical guidance report: gilteritnib (Xospata). | 2020 | CADTH |