The Lynx Group

FDA Approves Rezurock for the Treatment of Chronic Graft-versus-Host Disease

October 2021, Vol 12, No 5

On July 16, 2021, the FDA approved belumosudil (Rezurock; Kadmon Holdings), a kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after failure of ≥2 previous lines of systemic therapy. The FDA granted belumosudil breakthrough therapy designation and priority review for this indication.

“Rezurock represents a new treatment paradigm for thousands of [patients with chronic GVHD], including those with difficult-to-treat manifestations like fibrosis,” said Corey S. Cutler, MD, MPH, FRCPC, Associate Professor of Medicine, Harvard Medical School, and Medical Director, Adult Stem Cell Transplantation Program, Dana-Farber Cancer Institute, Boston, MA, in a press release. “Rezurock has shown robust and durable responses across the spectrum of chronic GVHD and is safe and well-tolerated, allowing patients to stay on therapy and achieve meaningful benefit from treatment.”

The FDA approved belumosudil based on results of the randomized, open-label ROCKstar trial of 65 patients with chronic GVHD who had received 2 to 5 previous lines of therapy. All patients received 200 mg belumosudil orally once daily. The primary end point was ORR.

The ORR was 75% (95% CI, 63%-85%) through cycle 7, day 1 of treatment, with 6% of patients achieving a complete response and 69% achieving a partial response. Median time to first response was 1.8 months, and median DOR was 1.9 months. Nearly two-thirds of patients (62%) did not require new systemic therapy for at least 12 months after achieving response.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were infections, hypertension, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, decreased lymphocytes and phosphate, and increased gamma-glutamyl transferase.

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