The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.
Kadmon Pharmaceuticals has selected Onco360 as the pharmacy provider for Rezurock (belumosudil). Onco360 in Louisville, K.Y., is a provider of oncology pharmacy services and dispenses nationally through its network of URAC-, ACHC-, and NABP digital-accredited pharmacies. It is a specialty pharmacy brand of PharMerica Corporation.
The FDA approved Rezurock on July 16 for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.
Rezurock is expected to be available by late August 2021
“As a provider of this key treatment, Onco360 is committed to supporting the highly specialized needs of chronic GVHD patients,” Benito Fernandez, chief commercial officer, Onco360, said in a statement.
Rezurock is the first FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes. The approval is based on safety and efficacy results from ROCKstar (KD025-213), a randomized, open-label, multicenter pivotal trial of Rezurock in 65 patients with cGVHD who had received two to five prior lines of systemic therapy.
The therapy achieved an overall response rate of 75% through cycle 7 day 1 of treatment with 6% of patients achieving a complete response and 69% achieving a partial response. Sixty-two percent (62%) of responders did not require new systemic therapy for at least 12 months following response.
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