FDA News

FDA grants priority review to Jakafi for acute graft-versus-host disease

The FDA granted priority review to ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, according to the agent’s manufacturer.

Ruxolitinib (Jakafi, Incyte) is a JAK1/JAK2 inhibitor approved for the treatment of individuals with polycythemia vera who have had inadequate response to or are intolerant of hydroxyurea. The agent also is approved for treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.

A supplemental new drug application seeking approval for the acute GVHD indication is based on results of the REACH1 study, which evaluated ruxolitinib in combination with corticosteroids among 71 patients with acute GVHD who had inadequate response to corticosteroids.

Researchers reported a 55% overall response rate at day 28, and a best overall response rate of 73%.

“Patients with acute GVHD face significant morbidity and mortality risk, underscoring the urgent need for new treatment options,” Steven Stein, MD, chief medical officer at Incyte, said in a company-issued press release. “If approved, ruxolitinib will be the first and only treatment available in the U.S. for patients with acute GVHD who have not responded adequately to corticosteroid therapy.”

The FDA previously granted breakthrough therapy designation to ruxolitinib for the acute GVHD indication. Ruxolitinib also received orphan drug designation for GVHD treatment.

The FDA granted priority review to ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, according to the agent’s manufacturer.

Ruxolitinib (Jakafi, Incyte) is a JAK1/JAK2 inhibitor approved for the treatment of individuals with polycythemia vera who have had inadequate response to or are intolerant of hydroxyurea. The agent also is approved for treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.

A supplemental new drug application seeking approval for the acute GVHD indication is based on results of the REACH1 study, which evaluated ruxolitinib in combination with corticosteroids among 71 patients with acute GVHD who had inadequate response to corticosteroids.

Researchers reported a 55% overall response rate at day 28, and a best overall response rate of 73%.

“Patients with acute GVHD face significant morbidity and mortality risk, underscoring the urgent need for new treatment options,” Steven Stein, MD, chief medical officer at Incyte, said in a company-issued press release. “If approved, ruxolitinib will be the first and only treatment available in the U.S. for patients with acute GVHD who have not responded adequately to corticosteroid therapy.”

The FDA previously granted breakthrough therapy designation to ruxolitinib for the acute GVHD indication. Ruxolitinib also received orphan drug designation for GVHD treatment.