Fostamatinib disodium hexahydrate

(Tavalisse®)

Fostamatinib disodium hexahydrate

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Drug updated on 5/17/2024

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.

Summary
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  • Fostamatinib disodium hexahydrate (Tavalisse) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments.
  • Three studies provided insights into Tavalisse's safety and effectiveness compared to other drugs such as HMPL-523, rilzabrutinib, avatrombopag, eltrombopag, and romiplostim.
  • In clinical trials involving 255 adult patients with relapsed/refractory ITP, where 101 were treated with fostamatinib, the overall response rate was 42.5%, the stable response rate was 17.8%, while serious adverse events occurred at low rates of 1%-2% including dizziness, hypertension, diarrhea, and neutropenia.
  • A network meta-analysis found that fostamatinib showed statistically significant improvements versus placebo in durable platelet response and incidence of any bleeding events, but no between-treatment differences were observed against eltrombopag or romiplostim specifically regarding bleeding incidents.
  • Another study aimed to rank the efficacy and safety of ITP medications suggested romiplostim as most suitable followed by avatrombopag, then eltrombopag before fostamatinib, which indicates its comparable safety profile among second-line treatments despite a lower efficacy ranking.
  • The focus on adults suffering from chronic ITP who haven't responded adequately to prior treatments underlines this drug's target patient population, indicating it may be considered for cases of relapsed or refractory ITP due to its challenging nature when treating this subgroup.