Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ). FDA label
Also known as BMS-847943
Fedratinib · 2 trials · 3 indications
Percentage of participants who have ≥ 35% spleen volume reduction (SVR) at end of cycle 6 A Cochran-Mantel-Haenszel (CMH) test to adjust for planned stratification factors (spleen size by palpation, platelet counts and refractory/relapsed or intolerance to ruxolitinib treatment). The RRs and 95% confidence intervals (CI) will be provided for each arm as well as for the difference in RRs and 95% confidence interval of the difference for fedratinib to BAT.
is the highest dose that causes DLTs in not more than 33% of the subjects treated with fedratinib in the first cycle with at least 3 evaluable subjects treated at this dose.
is a recommended Phase 2 dose that is determined as safe and tolerable by the Safety Review Committee based on the data from the first cycle with at least 3 evaluable subjects treated at each dose of the Phase 1 part.
Proportion of subjects who have ≥ 35% SVR at end of Cycle 6 from baseline
| Arm | Type | Description |
|---|---|---|
| Fedratinib 400mg/day | EXPERIMENTAL | Will include up to 128 subjects receiving fedratinib 400 mg self-administered Investigational Product (IP) on an outpatient basis, once daily preferably together with food during an evening meal at the same time each day in consecutive 4-week (28-day) cycles. |
| Best Available Therapy (BAT) | ACTIVE_COMPARATOR | Best-available Investigator-selected therapy included a number of available compounds to treat MF and/or its symptoms and was chosen by the investigator for each subject. Therapy changed at different times during the treatment period. No investigational agents (e.g. not approved for the treatment of any indication) were allowed. BAT also included the choice of no treatment. |
| Fedratinib Administration | EXPERIMENTAL | The fedratinib dose is 300 or 400 mg/day PO (3 or 4 x 100 mg capsules) to be self-administered orally once daily continuously on an outpatient basis, preferably together with food during an evening meal, the same time each day. |
| Name | Type | Description |
|---|---|---|
| FEDRATINIB | DRUG | A potent and selective inhibitor of JAK2 kinase activity |
| Best Available Therapy (BAT) | DRUG | Best available therapy (BAT) |
Inclusion Criteria: 1. Subject is at least 18 years of age at the time of signing the informed consent form (ICF) 2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2 3. Subject has diagnosis of primary myelofibrosis (PMF) according to the 2016 World Healt...
Fedratinib is used to treat primary myelofibrosis, a bone marrow cancer in the oncology therapeutic area. It is also being studied in post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis, which are related myeloproliferative conditions. It is a small molecule drug being developed by Bristol-Myers Squibb.
Fedratinib targets JAK2 and FLT3. It is an inhibitor of these kinases, meaning it blocks their activity. JAK2 signaling is central to the abnormal blood cell production seen in myelofibrosis, and FLT3 is another kinase in the same family. Both targets are named explicitly in the drug's development profile.
Fedratinib is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is the sponsor behind the clinical development program for the drug in myelofibrosis and related myeloproliferative conditions.
Fedratinib is in Phase 3 development for primary myelofibrosis. It is an investigational small molecule and is not described as approved. The Phase 3 program includes a completed active-controlled study, and a separate Phase 1 study in Japanese subjects is active and not recruiting.
Fedratinib has been studied in two trials. NCT03952039 is a completed Phase 3 study comparing fedratinib to best available therapy in patients previously treated with ruxolitinib, enrolling 202 participants across Europe, Asia, and Australia. NCT04446650 is an active Phase 1 study in Japanese subjects with myelofibrosis, enrolling 31 participants.
Yes. The Phase 3 trial of fedratinib, NCT03952039, is randomized and active-controlled, comparing the drug against best available therapy. It enrolled 202 participants and is completed. The Phase 1 Japanese study, NCT04446650, is not randomized and is active but not recruiting, with 31 participants enrolled.