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MF
PV

JAKAVI is the first therapy with 2 separate indications for myeloproliferative neoplasms (MPNs)

  • Approved for the treatment of patients with myelofibrosis (MF), including primary myelofibrosis, post-polycythaemia vera myelofibrosis, or post-essential thrombocythaemia myelofibrosis
  • Approved to treat patients with polycythaemia vera (PV) who are resistant or intolerant to hydroxyurea (HU)

Well-characterised safety profile established in extensive clinical studies and real-world experience

  • Safety profile assessed in multiple MF- and PV-specific trials, including the Phase III COMFORT and RESPONSE trials4,5,10
  • Estimated cumulative patient exposure to JAKAVI is more than 80,000 patient treatment years7

JAKAVI has been demonstrated in vitro to be a potent JAK inhibitor

  • JAKAVI binds to the kinase domain of JAK1 and JAK2 and inhibits JAK1 and JAK2 signalling, regardless of the JAK2V617F mutation status1
  • JAKAVI inhibits JAK stimulation of STAT and downstream effects on cellular proliferation1,4

BAT=best available therapy; CHR=complete haematologic remission; COMFORT=Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment; ITT=intent to treat; JAK=Janus kinase; QoL=quality of life; STAT=signal transducer and activator of transcription.

References:

  1. JAKAVI® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; May 2019.
  2. Verstovsek S, Gotlib J, Mesa RA, et al. Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses. J Hematol Onc. 2017;10(1):156.
  3. Harrison C, Niederwieser D, Vannuchi A, et al. Results from a 3.5 year update of COMFORT-II, a phase 3 study comparing ruxolitinib (RUX) with best available therapy (BAT) for the treatment of myelofibrosis. Abstract presented at: 19th Congress of the European Hematology Association; June 12-15, 2014; Milan, Italy.
  4. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.
  5. Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372(5):426-435.
  6. Mesa R, Verstovsek S, Kiladjian J-J, et al. Changes in quality of life and disease related symptoms in patients with polycythemia vera receiving ruxolitinib or best available therapy: RESPONSE trial results. Paper presented at: 56th ASH Annual Meeting and Exposition; December 6-9, 2014; San Francisco, CA.
  7. Data on file. Novartis Pharma AG. Basel, Switzerland.
  8. Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera [supplementary appendix]. N Engl J Med. 2015;372(5):1-25.
  9. Vannucchi AM, Kiladjian J-J, Griesshammer M, et al. Ruxolitinib proves superior to best available therapy in a prospective, randomized, phase 3 study (RESPONSE) in patients with polycythemia vera resistant to or intolerant of hydroxyurea. Paper presented at: 19th Congress of EHA; June 12-15, 2014; Milan, Italy.
  10. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.