News from the FDA/CDC

Ruxolitinib receives priority review for acute GVHD


The Food and Drug Administration has accepted the JAK1/JAK2 inhibitor ruxolitinib (Jakafi) for priority review.

Incyte is seeking approval for ruxolitinib as a treatment for patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids.

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“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,” Steven Stein, MD, chief medical officer at Incyte, said in a statement.

The FDA grants priority review to applications for products that may provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. The designation generally means that the agency will act on the application within 6 months, rather than 10 months.

In addition to priority review, the FDA previously granted ruxolitinib breakthrough therapy and orphan drug designations.

The application is based on data from the ongoing, phase 2 REACH1 trial (NCT02953678), which is evaluating ruxolitinib in combination with corticosteroids in patients who have steroid-refractory acute GVHD.

Incyte announced top-line results from REACH1 in June, reporting on outcomes in 71 patients.

The study’s primary endpoint – overall response rate at day 28 – was met. Ruxolitinib produced an overall response rate of 55% at that time. However, 73% of patients responded to ruxolitinib at some point during the trial. Incyte said the most common treatment-emergent adverse events were anemia, thrombocytopenia, and neutropenia.

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