REZUROCK™ (belumosudil) Tablets Approved to Treat Adult and Pediatric Patients 12 Years and Older With Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Lines of Therapy | Business
LOUISVILLE, Ky.–(BUSINESS WIRE)–July 21, 2021–
Onco360 ®, the nation’s largest independent oncology pharmacy, has been selected by Kadmon Pharmaceuticals, LLC as a specialty pharmacy partner for REZUROCK (belumosudil), a novel oral therapy for the treatment of adult and pediatric patients 12 years of age and older with chronic graft versus host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
“Onco360 is honored to be selected as a specialty pharmacy supplier for REZUROCK in partnership with Kadmon,” said Benito Fernandez, Chief Commercial Officer, Onco360. “The recent approval of REZUROCK represents the first FDA-approved therapy for chronic GVHD patients who have failed multiple alternative treatment options. As a provider of this important treatment, Onco360 is committed to supporting the highly specialized needs of chronic GVHD patients.”
ABOUT CHRONIC GRAFT-VERSUS-HOST-DISEASE
According to National Comprehensive Cancer Network (NCCN) guidelines for hematopoietic cell transplantation (HCT), chronic GVHD is the leading cause of non-recurrent mortality after allogeneic HCT. Chronic GVHD often develops within the first year after allogeneic HCT. Chronic GVHD can affect multiple organ systems including, but not limited to, skin, gastrointestinal tract, liver, lungs, eyes, muscles and joints and is characterized by fibrosis and variable clinical features similar to autoimmune diseases due to transplanted immune cells attack the patient’s body. host tissues. Although the first-line treatment for chronic GVHD includes systemic corticosteroids, up to 50% of patients will develop steroid-refractory disease and alternative treatment options will be needed. 1 Approximately 14,000 patients with chronic GVHD are currently living in the United States. 2
REZUROCK is distributed and marketed by Kadmon Pharmaceuticals LLC, a biopharmaceutical company that discovers, develops and markets transformative therapies for unmet medical needs. The FDA approval of REZUROCK is the result of the Phase II clinical study KD025-213 (NCT03640481) that demonstrated an overall response rate (ORR) of 75% after six cycles of therapy with an oral dose of 200 mg once daily in patients with chronic GVHD disease in which at least two lines of previous systemic therapy failed and required therapy due to worsening of their condition. 3 For complete prescribing information, visit Rezurock.com.
About Onco360 ® Oncology Pharmacy:
Onco360 is the largest independent oncology pharmacy and clinical support services company in the country. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and address the specialized needs of oncologists, patients, hospitals, cancer centers, manufacturers, health plans and payers. It distributes nationally through its network of URAC- and ACHC-accredited oncology dispensaries. Headquartered in Louisville, Kentucky, Onco360 is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion and hospital services serving healthcare facilities in the United States. For more information about Onco360, visit Onco360.com.
hct.pdf (nccn.org). Accessed July 2021. US FDA grants full approval of REZUROCK(TM) (belumosudil) for the treatment of patients with chronic graft-versus-host disease (cGVHD) (yahoo.com) label (fda.gov)
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CONTACT: Benito Fernandez, Chief Commercial Officer
KEYWORD: UNITED STATES NORTH AMERICA KENTUCKY
INDUSTRY KEY WORD: ONCOLOGY FDA HEALTH CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY
Copyright Business Wire 2021.
PUB: 21-07-21 12:00 PM/DISC: 21-07-21 12:01 PM
Copyright Business Wire 2021.