Drug updated on 11/1/2024
| Dosage Form | Tablet (oral; 5 mg, 10 mg, 15 mg, 20 mg, 25 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults
- Indicated for treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea
- Indicated for treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older
- Indicated for treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Latest News
Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Myelofibrosis (MF): Ruxolitinib (RUX) and momelotinib (MMB) were more effective in reducing spleen volume (SVR) and total symptom score (TSSR) compared to other JAK inhibitors, with MMB and pacritinib (PAC) showing a decreased risk of grade 3/4 anemia and thrombocytopenia. Fedratinib (FED) was particularly tolerable for patients with thrombocytopenia.
- Steroid-Refractory Graft-Versus-Host Disease (SR-GvHD): RUX achieved an overall response rate (ORR) ranging from 45% to 100%, with a complete response (CR) rate of 56% in acute GvHD (aGvHD) in children under 12 years and 11% in chronic GvHD (cGvHD). Patient response was not significantly influenced by age, weight, graft source, previous therapy lines, or dose.
- Acute Graft-Versus-Host Disease (aGvHD): RUX demonstrated superior ORR and CR at day 28, with higher long-term response durability by day 56 and longer failure-free survival compared to other treatments; inolimomab matched in 1-year therapy success but showed greater long-term overall survival compared to anti-thymocyte globulin.
- In Myelofibrosis (MF), PAC and MMB were associated with a decreased risk of grade 3/4 anemia and thrombocytopenia compared to other JAK inhibitors, with safety outcomes influenced by baseline characteristics, especially in patients with severe cytopenias.
- In Steroid-Refractory Graft-Versus-Host Disease (SR-GvHD), treatment-related toxicities occurred in 20% of patients, including cytopenia, liver toxicity, and infections, with a higher rate of toxicities observed specifically in acute GvHD (aGvHD) patients.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Jakafi (ruxolitinib) Prescribing Information. | 2023 | Incyte Corporation, Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| ERS/EBMT clinical practice guideline on treatment of pulmonary chronic graft-versus-host disease in adults. | 2024 | European Respiratory Journal |
| Management of Patients with Early Myelofibrosis: A Discussion of Best Practices. | 2024 | Current Hematologic Malignancy Reports |
| Myeloproliferative Neoplasms, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology. | 2022 | Journal of the National Comprehensive Cancer Network |
| Graft-Versus-Host Disease. | 2021 | Journal of the National Comprehensive Cancer |
| A guideline for the management of specific situations in polycythaemia vera and secondary erythrocytosis. A British Society for Haematology Guideline. | 2019 | British Journal of Haematology |