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A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Recruiting
19 years and older
All
Phase N/A
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Overview

The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review & Assessment Service.

Eligibility

Inclusion Criteria:

  • Participants 19 years of age or older
  • Participants who will receive fedratinib according to the approved label
  • For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered
  • Participants who signed the informed consent form

Exclusion Criteria:

  • Participants who have been prescribed fedratinib for an indication not approved in Korea
  • Participants who have been prescribed fedratinib at a dose not approved in Korea
  • Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Study details
    Primary Myelofibrosis
    Post-polycythemia Vera Myelofibrosis
    Post-essential Thrombocythemia Myelofibrosis

NCT06073847

Bristol-Myers Squibb

30 April 2024

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