Incyte Announces European Commission Approval of Jakavi® (ruxolitinib) as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease

  • Jakavi® (ruxolitinib) is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of steroid-refractory graft-versus-host disease (GVHD)1,2
  • In clinical trials, Jakavi demonstrated superiority versus best available therapy in patients with steroid-refractory/dependent acute and chronic GVHD, with overall response rates of 62% vs. 39%, and 50% vs. 26% respectively2,3
  • GVHD is a common and potentially life-threatening complication that arises in approximately half of patients following allogeneic stem cell transplants4

WILMINGTON, DE, USA I May 05, 2022 I Incyte (Nasdaq:INCY) today announced the European Commission (EC) has approved Jakavi® (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies. Ruxolitinib is marketed as Jakavi by Novartis in Europe and as Jakafi® by Incyte in the United States.

“Unfortunately, many people who receive allogenic stem cell transplants experience GVHD, and it is our hope that this Incyte-discovered medicine will make a significant impact for this patient population.”

“With the approval of this new indication for Jakavi, patients in Europe with acute or chronic GVHD who do respond to first-line steroid therapies have a new option that could redefine treatment for their condition,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “Unfortunately, many people who receive allogenic stem cell transplants experience GVHD, and it is our hope that this Incyte-discovered medicine will make a significant impact for this patient population.”

The approval of Jakavi follows the positive opinion granted in March 2022 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), based on the Phase 3 REACH2 and REACH3 clinical studies in which Jakavi demonstrated superiority in overall response rate (ORR) compared to best available therapy (BAT). Results of REACH2 showed 62% ORR with Jakavi at Day 28, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 (50% vs. 26%) with a higher best ORR (76% vs. 60%) vs. BAT, among steroid-refractory/dependent chronic GVHD patients2,3.

“Today, 30-60% of patients with GVHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” said Robert Zeiser, M.D., University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany and lead investigator of the REACH trials. “The approval of Jakavi offers healthcare providers and patients with GVHD who remain dependent on or refractory to steroids a new way to manage this debilitating and life-threatening condition.”

GVHD occurs when donor cells see the recipient’s healthy cells as foreign and attack them. Symptoms of GVHD can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs and joints. Approximately 50% of allogeneic stem cell transplant recipients will develop either acute or chronic GVHD. Both acute and chronic GVHD can be fatal and until now both have lacked an established standard of care for patients who do not adequately respond to first-line steroid treatment1,4-9. Currently, there are no other approved therapies for the treatment of GVHD after steroid failures in Europe1,2.

About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older10.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

References:
1 Jaglowski SM, et al. Graft-versus-Host Disease: Why Haven’t We Made More Progress? Curr Opin Hematol. 2014;21(2):141-147
2 Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory Chronic Graft-versus-Host Disease (REACH3). New England Journal of Medicine; July 2021.
3 Zeiser, R, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease (REACH2). New England Journal of Medicine. April 2020.
4 Leukemia and Lymphoma Society. Graft-Versus-Host Disease Overview. 2021. Available at: https://www.lls.org/treatment/types-treatment/stem-cell-transplantation/graft-versus-host-disease
5 Jakavi (ruxolitinib) Summary of Product Characteristics. Novartis Pharma AG; 2022.
6 Ferrara JL., et al. Graft-versus-host disease. Lancet. 2009;373(9674):1550-1561.
7 Zeiser R., et al. Pathophysiology of Chronic Graft-versus-Host Disease and Therapeutic Targets. N Engl J Med. 2017 Dec 28;377(26):2565-2579
8 Jagasia MH, et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015.
9 Martin PJ, Rizzo JD, Wingard JR, et al. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2012;18(8):1150-1163.
10 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug Administration.

SOURCE: Incyte

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