Drug updated on 12/11/2024
| 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 janus kinase (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. 4. 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 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 |