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Fostamatinib disodium hexahydrate

(Tavalisse®)

Tavalisse®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 100 mg, 150 mg)
Drug ClassKinase 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.

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Summary
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  • 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.