This article is more than 5 years old. Information may no longer be current.

FDA grants Jakafi breakthrough designation to treat acute GVHD

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA granted ruxolitinib breakthrough therapy designation for the treatment of patients with acute graft-versus-host disease.

No therapy is currently FDA–approved for acute GVHD.

Ruxolitinib (Jakafi, Incyte) — a first-in-class JAK1/JAK2 inhibitor — is currently indicated for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea, and for patients with intermediate- or high-risk myelofibrosis.

“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to-date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” Steven Stein, MD, chief medical officer of Incyte, said in a company-issued press release. “We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible.”