Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 100 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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).
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Spleen Volume Reduction (SVR): Ruxolitinib (RUX) demonstrated superior effectiveness in achieving SVR in patients with myelofibrosis. Momelotinib (MMB) was comparable to RUX, while Fedratinib (FED) was also effective for splenomegaly and constitutional symptoms, matching RUX in first-line therapy. Pacritinib (PAC) showed less effectiveness for splenomegaly in first-line treatment but was effective in second-line treatment after RUX exposure.
- Total Symptom Score Reduction (TSSR): RUX exhibited superior effectiveness in achieving TSSR, with MMB showing comparable results. FED effectively reduced constitutional symptoms, similar to RUX.
- Population Considerations: Patients with severe cytopenias experienced poorer overall survival (OS) outcomes with certain PAC dosages, while MMB showed positive effects on anemia, and FED was more tolerable for patients with thrombocytopenia. Personalized dosing strategies are recommended to balance efficacy and safety, considering baseline patient characteristics.
- Hematological Safety Profiles: FED is more tolerable for patients with thrombocytopenia, while MMB and PAC are associated with a decreased risk of grade 3/4 anemia and thrombocytopenia compared to other Janus kinase (JAK) inhibitors. Ruxolitinib (RUX) has a higher risk of anemia and thrombocytopenia compared to FED and MMB.
- Overall Outcomes: In patients with severe cytopenias, certain dosages of PAC resulted in poorer overall survival outcomes, suggesting that patient baseline characteristics significantly influence safety and treatment effectiveness.
- Specific Population Types: In patients with severe cytopenias, certain dosages of PAC were associated with poorer overall survival outcomes, indicating the importance of baseline characteristics in treatment efficacy. MMB has a positive effect on anemia, while FED is noted for its greater tolerability in patients with thrombocytopenia, suggesting personalized dosing strategies may optimize treatment efficacy and safety.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Inrebic (fedratinib) Prescribing Information. | 2024 | Bristol-Myers Squibb, New York, NY |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Comparative efficacy and hematologic safety of different dosages of JAK inhibitors in the treatment of myelofibrosis: a network meta-analysis | 2024 | Frontiers in Oncology |
| Efficacy and tolerability of Janus kinase inhibitors in myelofibrosis: a systematic review and network meta-analysis | 2021 | Blood Cancer Journal |