FDA Approves First Drug for Steroid-Refractory Acute Graft-Versus-Host Disease (GVHD)

In 2019 Incyte’s drug Jakafi (ruxolitinib) became the first medication FDA approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.  Each year in the US about half of the patients who develop acute GVHD do not respond adequately to steroids, which is why it is such an extremely challenging drug to treat. The FDA granted Jakafi breakthrough therapy designation and orphan drug designation for this indication, additionally the supplemental New Drug Application was reviewed under the FDA’s priority review program.  Jakafi is a first in its class JAK1/JAK2 inhibitors that is also indicated for treatment of polycythemia vera in adults who had an inadequate response and or are intolerant to hydroxyurea, as well as intermediate or high-risk myelofibrosis.  The typical dosage is 5mg PO twice daily, then increased to 10mg PO twice daily after three days without experiencing any toxicity. The most frequently encountered adverse effects were infections and edema. The most common laboratory abnormalities were anemia, thrombocytopenia, and neutropenia. 

By: Maggie Vricos, PharmD Candidate 2021

For full article, visit: https://www.clinicaloncology.com/FDA-Watch/Article/05-19/FDA-Approves-Jakafi-to-Treat-Acute-GVHD/55095

See package insert: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf

Leave a comment

Your email address will not be published.

Web Design by Venbit
Privacy Policy