Drug updated on 7/25/2024
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
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Summary
- Ruxolitinib (Jakafi) is indicated for the treatment of intermediate or high-risk myelofibrosis, polycythemia vera in adults intolerant to hydroxyurea, and steroid-refractory acute and chronic graft-versus-host disease in patients 12 years and older.
- The review included a total of 11 studies from systematic reviews/meta-analyses.
- In pediatric patients with steroid-refractory GvHD, Ruxolitinib showed an overall response rate (ORR) ranging from 45% to 100%, with complete response rates between 9% to 67% for acute GvHD and up to 28% for chronic GvHD. Approximately 20% experienced treatment-related toxicities such as cytopenia, liver toxicity, and infections.
- For adult patients with steroid-refractory GvHD, Ruxolitinib demonstrated higher ORR and CR rates at day 28 compared to other regimens. Common adverse events included cytopenia and infectious complications.
- In treating intermediate or high-risk myelofibrosis based on COMFORT-I/II trials data analysis, early initiation (\<=12 months from diagnosis) led to improved overall survival (OS), durable spleen volume reduction (SVR), and reduced thrombocytopenia/anemia rates compared to placebo/best available therapy.
- Safety concerns include an increased risk of herpes zoster infection during initial phases but decreased overall infection risk over extended use periods in myeloproliferative neoplasms treatments, indicating better long-term adaptation by patients.
- Comparatively among JAK inhibitors, while Fedratinib/Momelotinib had similar efficacy on spleen reduction/symptom score, Momelotinib was safer regarding anemia issues whereas Pacritinib showed potential as second-line post-JAK inhibitor exposure despite being less effective initially than Ruxolitinib in first-line usage against myelofibrosis symptoms.
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 |