The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.
Incyte announced today that the U.S. Food and Drug Administration (FDA) approved its Jakafi (ruxolitinib) to treat chronic graft-versus-host disease (GVHD).
The news comes just a day after the regulator gave its atopic dermatitis cream, Opzelura (ruxolinitib), the green light for short-term and non-continuous chronic treatment of mild to moderate AD.
Jakafi is indicated for adults and pediatric patients aged at least 12 years diagnosed with GVHD and who had undergone one or two lines of systemic therapy and failed. The FDA’s approval is based on positive results from its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy (BAT) for treating steroid-refractory chronic GVHD after allogeneic stem cell transplantation.
GVHD is a condition that can occur following an allogeneic stem cell transplant in which the donated cells initiate an immune response and start to attack the transplant recipient’s organs. It is classified as either acute (happening within 100 days from the surgery) and chronic (emerging after 100 days). Both types are linked with significant morbidity and can affect multiple organ systems.
Jakafi is formulated to help patients with chronic GVHD who generally face a poor prognosis.
“GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies. Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today’s approval of Jakafi for certain people who develop chronic GVHD.” said Steven Stein, M.D., the chief medical officer of Incyte, in a statement.
The Phase III REACH 3 trial met its primary endpoint of overall response rate in the 24th week, with Jakafi rating 49.7% against the BAT’s 25.6%. There were hematologic adverse reactions observed, such as thrombocytopenia and anemia, and non-blood related viral infections.
Jakafi’s supplemental New Drug Application (sNDA) for chronic GVHD was evaluated under the FDA’s Priority Review program and the Project Orbis program of the FDA Oncology Center of Excellence.
“In the U.S., there are over 14,000 people living with chronic GVHD, many of whom face significant complications that may impair daily activities and linger for years. The approval of Jakafi is an exciting development for the GVHD community and an important step forward in the treatment of a disease with few options,” commented Susan Stewart, the executive director of BMT InfoNet, in the same release.
Aside from GVHD, Jakafi is indicated for the treatment of polycythemia vera (PV) in adults. Incyte takes care of marketing the drug in the U.S. while Novartis handles it outside the country.
