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The graft-versus-host disease therapy has also been added to NCCN Guidelines.
Two specialty pharmacies are partnering with Kadmon Pharmaceuticals to dispense Rezurock(belumosudil) tablets for patients in the United States with chronic graft-versus-host disease (cGVHD): Amber Specialty Pharmacy and Onco360.
In July, the FDA approved Rezurock 200-mg once daily (QD) for the treatment of adult and pediatric patients 12 years and older after failure of at least two prior lines of systemic therapy. The therapy is a small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes.
Additionally, the National Comprehensive Cancer Network (NCCN) has added Rezurock to the NCCN Clinical Practice Guidelines in Oncology as a Category 2A designation as a suggested systemic agent in the guideline titled “Hematopoietic Cell Transplantation (HCT) in the Pre-Transplant Recipient Evaluation and Management of Graft-Versus-Host Disease (GVHD).”
“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,” Harlan W. Waksal, M.D., president and CEO of Kadmon said in a statement. “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 FDA approval is based on safety and efficacy results from ROCKstar (KD025-213), a randomized, open-label, multicenter pivotal trial in patients with cGVHD who had received two to five prior lines of systemic therapy. Based on this study, the NCCN guidelines suggest that “belumosudil is a promising therapy for steroid-refractory cGVHD that is well tolerated and produces clinically meaningful responses.”