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

 

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

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

Using JAKAVI® early may increase benefits for patients with myelofibrosis4,5

Using JAKAVI early symptom response

An ad-hoc analysis of JUMP showed that low-risk patients achieved significantly greater spleen size reductions vs high-risk patients, suggesting that earlier JAKAVI® treatment may lead to greater benefits in patients with myelofibrosis.5

 

Treating early with JAKAVI® may increase OS for intermediate-2 patients2

COMFORT-I and -II pooled analysis: long-term OS by risk group

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.6

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.1,7

JUMP was a Phase 3b expanded-access trial assessing the safety and efficacy of JAKAVI® (N=2233) in patients with a diagnosis of primary or secondary MF (WHO criteria). Patients with intermediate- or high-risk MF (n=1114), intermediate-1-risk MF (n=163) and low-risk MF (n=60) were included in the study. The primary endpoint was assessment of JAKAVI® safety and tolerability by the frequency, duration and severity of AEs.5,8

*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.1,7
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
OR=0.25, 95% CI (0.13–0.47), p<0.001.4
§A symptom response is defined as a ≥50% reduction in the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS).4
llData from a retrospective analysis of 408 patients with MF treated with JAKAVI®.4
Data from an ad-hoc analysis of the safety and efficacy of JAKAVI® in a subset of patients in JUMP with DIPSS low-risk MF (n=60).5

 

AE, adverse event; BAT, best available therapy; CI, confidence interval; COMFORT, Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; CT, computed tomography; DIPSS, dynamic international prognostic scoring system; 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; OR, odds ratio; OS, overall survival; PV, polycythaemia vera; WHO, World Health Organization.

 

  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. Palandri F, et al. Onco target. 2017;8:79073–79086.
  5. Guglielmelli P, et al. EHA 2018, 14–17 June; Stockholm, Sweden. Poster PF623.
  6. Novartis Pharmaceuticals UK Ltd. JAKAVI® summary of product characteristics.
  7. Verstovsek S, et al. N Engl J Med. 2012;366:799–807.
  8. Ali-Ali H, et al. Haematologica. 2016;101:1065–1073.
 

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UK | August 2021 | 134488
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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
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