Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 100 mg, 150 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Overall Platelet Response in Refractory Immune Thrombocytopenia (ITP): Fostamatinib achieved a weighted mean proportion of overall platelet response of 0.70 (95% confidence interval (CI): 0.62, 0.76) and an overall response rate of 42.5% in patients. It also achieved a partial response in 48% of patients (weighted mean proportion: 0.48 [0.36, 0.61]) and a stable response in 28% of patients, with a stable response rate of 17.8% reported.
- Comparison with Other Treatments: Fostamatinib demonstrated a higher overall response compared to placebo. In comparison, romiplostim was identified as the most suitable treatment in terms of overall response, with avatrombopag, eltrombopag, and fostamatinib following in efficacy. HMPL-523 achieved an overall response rate of 55% and a stable response rate of 25%.
- Subgroup Analysis for Low Platelet Counts: Fostamatinib showed improved platelet counts specifically in subjects with baseline platelet counts of less than 15,000/microL, indicating its potential effectiveness in this severely affected population.
- Adverse Events in Fostamatinib Patients: Patients receiving fostamatinib had a higher likelihood of experiencing hypertension (relative risk (RR) 2.33; 95% CI 1.00-5.43), diarrhea (RR 2.32; 95% CI 1.11-4.84), and abnormal liver function tests (RR 4.18; 95% CI 1.00-17.48). Serious adverse events included dizziness (1%), hypertension (2%), diarrhea (1%), and neutropenia (1%).
- Comparison of Adverse Events with Other Treatments: Avatrombopag was associated with a statistically significant lower incidence of bleeding events compared to eltrombopag and romiplostim.
- Population Types and Subgroup Considerations: The evidence primarily focuses on adults aged ≥ 18 years with refractory immune thrombocytopenic purpura (ITP) and includes findings that fostamatinib improved platelet counts in subjects with baseline counts of less than 15,000/microL, highlighting its efficacy in severely affected patients.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tavalisse (fostamatinib disodium hexahydrate) Prescribing Information. | 2020 | Rigel Pharmaceuticals, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The 2022 review of the 2019 American Society of Hematology guidelines on immune thrombocytopenia | 2024 | Blood Advances |
Recommendations for the Clinical Approach to Immune Thrombocytopenia: Spanish ITP Working Group (GEPTI) | 2023 | Journal of Clinical Medicine |
American Society of Hematology 2019 guidelines for immune thrombocytopenia. | 2019 | Blood Advances |