Kadmon Holdings Inc. (NASDAQ: KDMN) has announced the addition of REZUROCK (belumosudil) tablets by the National Comprehensive Cancer Network to the NCCN Clinical Practice Guidelines in Oncology for Hematopoietic Cell Transplantation in the Pre-Transplant Recipient Evaluation and Management of Graft-Versus-Host Disease. Currently, NCCN Guidelines in the US include REZUROICK with category 2A certification as a proposed systematic steroid-refractory chronic GVHD agent.
REXUROCK included in NCCN guidelines
CEO Harlan W. Waksal said, “The rapid inclusion of REZUROCK into the NCCN guidelines shortly after full FDA approval validates the potential clinical impact of REZUROCK in this difficult-to-treat therapeutic landscape. We are grateful for this important development as we continue in our efforts to increase awareness of REZUROCK among the healthcare provider community and patients living with chronic GVHD.”
The US Food and Drug Administration authorized REZUROCK 200 mg once daily on July 16, 2021, to treat chronic graft-versus-host disease in adults and children above 12 years who have failed at least two previous lines of systemic therapy.
ROCKstar study results used to approve REZUROCK
Based on the efficacy and safety results of the ROCKstar (KD025-213) study, the FDA approved REZUROCK. ROCKstar was an open-label, randomized, multicenter pivotal REZUROCK study in patients with cGVHD with 2-5 five systemic treatment lines. According to the study, belumosudil is a potential therapy for steroid-refractory cGVHD that is well tolerated and provides a clinically substantial response. cGVHD occurs after allogeneic cell transplantation leading to mortality.
REZUROCK is the first and only FDA-approved medication that targets the Rho-associated coiled-coil kinase 2 (ROCK2) signaling system, which regulates inflammation and fibrotic processes. REZUROCK received Breakthrough Therapy designation and Priority Review from the FDA, which also reviewed the NDA as part of the Real-Time Oncology Review (RTOR) test program.
Kadmon is working on a therapy for systemic sclerosis called belumosudil. The FDA has designated belumosudil as an orphan drug for the treatment of systemic sclerosis.