Fostamatinib disodium hexahydrate

(Tavalisse®)

Tavalisse®

Drug updated on 9/4/2024

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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  • Tavalisse (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
  • This summary is based on the review of three systematic reviews/meta-analyses. [1-3]
  • Fostamatinib (Tavalisse): Demonstrated a stable response (SR) in 17.8% (18/101) of patients and an overall response (OR) in 42.5% (43/101) of patients. In comparison, the placebo group showed an SR of 2% (1/49) and an OR of 14% (7/49).
  • Comparative Effectiveness: Rilzabrutinib had a higher SR (28% vs 17.8%) compared to fostamatinib. HMPL-523 showed superior SR (25% vs 17.8%) and OR (55% vs 42.5%) compared to fostamatinib.
  • Avatrombopag, Eltrombopag, Romiplostim: These drugs were associated with significant improvements in durable platelet response and a reduced need for rescue therapy, with Romiplostim ranking highest in overall and early responses.
  • Fostamatinib (Tavalisse) is associated with serious adverse events including dizziness (1%), hypertension (2%), diarrhea (1%), and neutropenia (1%), whereas Rilzabrutinib and HMPL-523 did not require dose reductions due to drug-related adverse effects.
  • Avatrombopag significantly reduced the incidence of any bleeding events compared to placebo, eltrombopag, and romiplostim, with no statistically significant differences in adverse events compared to other drugs.
  • The reviewed studies focused on adult patients (≥18 years old) with chronic immune thrombocytopenia (ITP) who have relapsed or refractory ITP with insufficient response to prior treatment; significant efficacy (OR, SR) and safety outcomes were observed across subgroups, particularly with fostamatinib, avatrombopag, eltrombopag, and romiplostim.