Following today’s news (Thursday 23 July) that Incyte’s Jakafi (ruxolitinib) met its primary endpoint in its Phase III REACH-3 chronic graft-versus-host-disease (GvHD) study;

James Mather, MChem, Managing Immunology & Respiratory Analyst at GlobalData, a leading data and analytics company, offers his view:

“In the top-line results announced by Incyte, Jakafi demonstrated a superior overall response rate in patients with chronic GvHD, compared with the best available therapy. These positive results mean that Jakafi, which was co-developed with Novartis, is now set to become the first treatment approved by the Food and Drug Administration (FDA) for the treatment of both acute and chronic GvHD.

“Approval of Jakafi in both acute and chronic GvHD will inevitably lead to physician’s becoming much more familiar with its use in this high-risk patient population. GlobalData forecasts that the US GvHD market will grow rapidly over the next few years, driven primarily by the launch of new products as well as an expanding patient population, to reach a value of $481m by 2028. Due to robust safety and efficacy data and its approval in both acute and chronic GvHD, GlobalData expects that Jakafi will become the first-line option for GvHD patient failing steroid therapy.

“There is currently just one approved therapy for steroid-refractory chronic GvHD in the US – Janssen and AbbVie’s Imbruvica (ibrutinib). However, this is set to change rapidly with Kadmon’s belumosudil and now Incyte’s Jakafi expected to receive approval in mid-2021.

“Jakafi became the first FDA approved treatment for steroid-refractory acute GvHD in May 2019 based on the promising results of its Phase II REACH-1 study. The decision to grant approval based on limited data was shown to be a shrewd one, as in April this year its Phase III REACH-2 study reinforced those earlier findings.”