FDA approves Rezurock for chronic GVHD
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The FDA today approved belumosudil for treatment of patients aged 12 years or older with chronic graft-versus-host disease, according to the agent’s manufacturer.
The approval of belumosudil (Rezurock, Kadmon Holdings) — a novel oral selective rho-associated coiled-coil kinase 2 (ROCK2) inhibitor — applies to patients who failed at least two previous lines of systemic therapy.
“Rezurock represents a new treatment paradigm for thousands of [patients with chronic GVHD], including those with difficult-to-treat manifestations like fibrosis,” Corey S. Cutler, MD, MPH, FRCPC, associate professor of medicine at Harvard Medical School and medical director of the adult stem cell transplantation program at Dana-Farber Cancer Institute, said in a company-issued 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 based the approval on results of the randomized, open-label ROCKstar trial, which included 65 patients with chronic GVHD who received 200 mg belumosudil orally once a day. Patients had received two to five previous lines of therapy. Median time from diagnosis to enrollment was 25.3 months. About half of the patients (48%) had at least four organs involved, and 78% were refractory to their last treatment.
As Healio previously reported, overall response rate served as the study’s primary endpoint.
Results showed an ORR of 75% (95% CI, 63-85) through day 1 of treatment cycle seven, including 6% with a complete response and 69% with a partial response. Median time to first response was 1.8 months, and median duration of response was 1.9 months.
Nearly two-thirds of patients (62%) did not need new systemic therapy for at least 12 months after achieving response.
Researchers reported that belumosudil appeared well-tolerated and adverse events were consistent with those of patients with advanced chronic GVHD who received corticosteroids and/or other immunosuppressants.
“We are proud to introduce Rezurock as a new treatment that uniquely addresses the underlying inflammatory and fibrotic pathophysiology of chronic GVHD,” Harlan W. Waksal, MD, Kadmon president and CEO, said in the press release. “Thank you to the patients, their families and caregivers, who are the center of our focus in achieving this significant milestone. We have built a hematology/oncology-experienced commercial team and we look forward to rapid adoption of Rezurock for patients in need.”
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