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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Post-essential Thrombocythemia Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Primary Myelofibrosis

Treatments: Drug: Fedratinib

Study type: Observational

Funder types: Industry

Identifiers

NCT06073847

CA054-005

Details and patient eligibility

About

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.

Enrollment: 137 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

137 participants in 1 patient group

Participants with myelofibrosis receiving fedratinib

Treatment:

Drug: Fedratinib