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FDA approves once-daily, extended-release tablet formulation of ruxolitinib for GvHD
On May 1, 2026, the U.S. Food and Drug Administration (FDA) approved a once-daily (QD), extended-release tablet formulation of ruxolitinib for patients aged ≥12 years with steroid-refractory acute graft-versus-host disease (aGvHD) or chronic graft-versus-host disease (cGvHD) after 1–2 prior lines of systemic therapy.1
The approval was based on a phase I clinical trial (NCT06555081) evaluating the bioequivalence of ruxolitinib extended-release (XR) tablets vs ruxolitinib immediate-release (IR) tablets in healthy adults.2 A single 55 mg XR tablet administered QD was shown to be bioequivalent to a single 25 mg IR tablet administered twice daily (BD), with steady-state exposure supporting comparable 24-hour ruxolitinib exposure.2 The safety profile for ruxolitinib was established in previous studies of ruxolitinib in adult and pediatric patients with aGvHD and cGvHD.1 The most common adverse reactions reported in patients with aGvHD included thrombocytopenia, anemia, leukopenia, infections, and swelling. In patients with cGvHD, the most common adverse reactions included anemia, thrombocytopenia, and infections, including viral infections.1
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What do you consider to be the main potential advantage of mesenchymal stromal cells in the treatment of acute GvHD?
