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JAKAVI® (ruxolitinib) in myelofibrosis
JAKAVI® is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. JAKAVI® is also indicated for adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.1
For your eligible myelofibrosis (MF) patients with disease-related splenomegaly or symptoms1–6
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Treatment with JAKAVI® can help reduce:
Spleen size vs BAT: 28% of patients treated with JAKAVI® (n=41/144) achieved at least a 35% reduction in spleen volume at Week 48 compared to 0% of patients treated with BAT (n=0/72) (p<0.001, primary endpoint)*7
To learn more about how JAKAVI® can help your patients with splenomegaly, click here
In the COMFORT-I trial, the proportion of patients with a reduction of 35% or more in spleen volume from baseline at Week 24 (primary endpoint) was 41.9% in the JAKAVI® group vs 0.7% in the placebo group (n=309) (OR=134.4; 95% CI: 18.0 to 1004.9; p<0.001)6
Median spleen volume at baseline (range): JAKAVI® 2598 cm³ (478–7462); placebo 2566 cm³ (521–8881)6
Symptom burden vs placebo: 45.9% of patients treated with JAKAVI® (n=68/149) achieved an improvement of 50% or more in the total symptom score from baseline to Week 24 compared to 5.3% of patients treated with placebo (n=8/152) (OR=15.3; 95% CI: 6.9–33.7; p<0.001) (prespecified secondary endpoint)†6
Modified MFSAF v2.0, TSS at baseline: JAKAVI® mean 18.2 (range 0–50.1); placebo mean 16.9 (range 0–52.7)8
To learn more about how JAKAVI® can help with symptom control, click here
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Recommended by the BSH guidelines as a treatment option and reimbursed across the UK in eligible patients.2,9,10
NICE recommendation:10
JAKAVI® is recommended as an option for treating disease-related splenomegaly or symptoms in adults with primary MF (also known as chronic idiopathic MF), post polycythaemia vera MF or post essential thrombocythaemia MF, only in people with intermediate‑2 or high-risk disease, and if the company provides ruxolitinib with the discount agreed in the patient access scheme.
People whose treatment with JAKAVI® is not recommended in this NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.
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Results from the 5-year pooled data from the COMFORT studies (OS data was not significant in COMFORT-II):
In an analysis of 5-year pooled data from the COMFORT studies, the risk of death (exploratory endpoint) was observed to be reduced by 30% in patients randomised to JAKAVI® (n=301) vs control (n=227, placebo in COMFORT-I, BAT in COMFORT-II) (absolute risk rate=9%); median OS (JAKAVI® vs control), 5.3 vs 3.8 years (HR=0.70; 95% CI, 0.54–0.91; p=0.0065).11
To learn more about the overall survival data with JAKAVI®, click here
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Generally well-characterised safety profile.1
The most frequently reported adverse drug reactions were thrombocytopenia and anaemia.
Haematological adverse drug reactions (any Common Terminology Criteria for Adverse Events [CTCAE] grade) included anaemia (83.8%), thrombocytopenia (80.5%) and neutropenia (20.8%).
Please refer to the SmPC for the full safety profile.
For more information about the safety profile of JAKAVI® in MF, click here
By clicking on the links above you will be directed to Novartis promotional websites.
*Spleen volume was assessed by MRI, or by CT for patients in whom MRI was contraindicated or in facilities where MRI was not readily available. Spleen length was assessed by manual palpation at every study visit using a soft centimetre ruler from the costal margin to the point of greatest splenic protrusion.6
†COMFORT-I: randomised, double-blind, Phase III trial comparing efficacy and safety of JAKAVI® (n=155) with placebo (n=154) in patients with intermediate-2 or high-risk MF. 41.9% of patients in the JAKAVI® group achieved a reduction in spleen volume of 35% or more at Week 24 (primary endpoint) vs with 0.7% in the placebo group (OR=134.4; 95% CI: 18.0–1004.9, p<0.001).6 COMFORT-II: randomised Phase III trial comparing JAKAVI® (n=146) with BAT (n=73, any commercially available agents as monotherapy or in combination, or no therapy at all) in patients with primary MF, post-PV MF or post-ET MF.6
BAT, best available therapy; BSH, British Society for Haematology; CI, confidence interval; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CT, computed tomography; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire; ET, essential thrombocythaemia; FACT-Lym, The Functional Assessment of Cancer Therapy-Lymphoma; HR, hazard ratio; JAK, janus kinase; MF, myelofibrosis; MFSAF, myelofibrosis symptom assessment form; MRI, magnetic resonance imaging; NHS, National Health Service; OR, odds ratio; NICE, National Institute for Health and Care Excellence; OS, overall survival; PV, polycythaemia vera; TSS, total symptom score.
References
JAKAVI® (ruxolitinib) Summary of Product Characteristics.
Scottish Medicines Consortium. Ruxolitinib (Jakavi®). Available at: https://scottishmedicines.org.uk/medicines-advice/ruxolitinib-jakavi-fullsubmission-86713/ [Accessed November 2025].
Vannucchi AM, et al. N Engl J Med 2015;372:426–435.
Verstovsek S, et al. Haematologica 2016;101:821–829.
Griesshammer M, et al. Ann Hematol 2018;97:1591–1600 and supplementary appendix.
Verstovsek S, et al. N Engl J Med 2012;366:799–807.
Harrison C, et al. N Engl J Med 2012;366:787–798.
Mesa RA, et al. J Clin Oncol 2013;31(10):1285–1292.
Reilly J, et al. Br J Haematol 2014;167:418–438.
National Institute for Health and Care Excellence. Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis [TA386]. Available at: https://www.nice.org.uk/guidance/ta386 [Accessed November 2025].
Verstovsek S, et al. J Hematol Oncol 2017;10:156.
UK | November 2025| FA-11346455-2
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
Welcome to Pro.Novartis.com
The Novartis portal for UK healthcare professionals (HCPs) and other relevant decision makers* is where you can find promotional information about Novartis products, therapy area materials and professional resources.
*Other relevant decision makers particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.
This website is designed to be viewed on desktop.
Welcome to Pro.Novartis.com
The Novartis portal for UK healthcare professionals (HCPs) and other relevant decision makers* is where you can find promotional information about Novartis products, therapy area materials and professional resources.
*Other relevant decision makers particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.
This website is designed to be viewed on desktop.