Prescribing information

 

JAKAVI® offers rapid and durable improvements in splenomegaly and MF-related symptoms*1

Significantly more patients achieved at least a 35% reduction in spleen volume at Week 48 with JAKAVI® (n=146), compared with patients in the BAT (n=73) group (28% vs 0%, p<0.001).*1

Image showing a range of improvements in spleen size with -56% reduction with Jakavi and +4% increase with BAT

 

Patients on JAKAVI® experienced reductions in MF-related symptoms, whereas patients receiving BAT had a worsening of symptoms.1

Bar graph showing the mean change from baseline in EORTC QLQ-C30 symptom scores to Week 48 in the COMFORT-2 trial of Jakavi vs BAT

JAKAVI® helps prolong median OS by 1.5 years in intermediate-2 and high-risk patients compared with BAT or placebo2

In a post-hoc analysis of COMFORT-I and COMFORT-II, each 10% reduction from baseline in spleen length at Week 24 with JAKAVI® was associated with a 9% reduction in the risk of death.†3

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.4

COMFORT-I was a randomised, double-blind, placebo-controlled trial in patients with intermediate-2 or high-risk myelofibrosis. COMFORT-II was a randomised trial comparing JAKAVI® with BAT in patients with primary MF, post-PV MF or post-ET MF. The JAKAVI® treatment group consisted of 155 patients in COMFORT-I and 146 patients in COMFORT-II. The primary endpoint was the proportion of patients with a reduction of ≥35% in spleen volume from baseline to Week 24 and to Week 48, respectively.1,5

* Patients treated with JAKAVI® achieved reduction in spleen length at Week 4, confirmed by reduction in spleen volume at Week 24, which was maintained to Week 48, and improvement in symptoms at Week 4, maintained to Week 24. The median time to 1st CT/MRI observation of a ≥35% reduction in spleen size was 12.3 weeks.1,5
Exploratory analysis of 5-year data pooled from the Phase 3 COMFORT-I and COMFORT-II trials. Overall survival was a secondary endpoint in both trials.2

BAT, best available therapy; CI, confidence interval; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CT, computed tomography; EORTC QLQ-C30, European Organization for Research and Treatment core quality of life questionnaire version 3.0; ET, essential thrombocythaemia; HR, hazard ratio; MF, myelofibrosis; MRI, magnetic resonance imaging; NE, not evaluated; OS, overall survival; PV, polycythaemia vera.

  1. Harrison C, et al. N Engl J Med. 2012;366:787–798. 
  2. Verstovsek S, et al. J Hematol Oncol. 2017;10:156.
  3. Vannucchi A, et al. Haematologica. 2015;100:1139–1145.
  4. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics.
  5. Verstovsek S, et al. N Engl J Med. 2012;366:799–807.

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UK | May 2021 | 119283
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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 via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]