LOUISVILLE, Ky.--(BUSINESS WIRE)--Onco360®, the nation’s largest independent Oncology Pharmacy, announced today that it was selected to be a specialty pharmacy network partner for Karyopharm’s new product Nubeqa® (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
“Onco360 is honored to be selected as a specialty pharmacy provider for Nubeqa® patients,” said Paul Jardina, President and CEO, Onco360. “The recent approval of Nubeqa® provides another treatment option for patients with non-metastatic castration-resistant prostate cancer (nmCRPC). As a provider of this key treatment, Onco360 will utilize its expertise in service delivery, clinical, healthcare professional and community engagement, insurance and billing, and ongoing customer service to support the highly specialized needs of CRPC patients and their physicians.”
Prostate cancer is the second most commonly diagnosed malignancy and fifth leading cause of cancer in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer and about 358,000 died from the disease worldwide. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man's reproductive system. It mainly affects men over the age of 50, and the risk increases with age. Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists (i.e. substances that stop the formation of testosterone or prevent its effect at the target location.) However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.
CRPC is an advanced form of the disease, where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is rapidly evolving. However, until two years ago, there have been no FDA-approved treatment options for nmCRPC patients with prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level. About one-third of men with nmCRPC go on to develop metastases within two years. In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.
Manufactured by Bayer, Nubeqa® was approved by the U.S. FDA on July 30, 2019 Phase III ARAMIS trial, evaluating Nubeqa® plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001). Nubeqa® was approved under the FDA's Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions.
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 serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans and payers. It dispenses nationally through its network of URAC-, ACHC- JCAHO- and VIPPS-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading pharmacy company in the U.S. serving institutional and community customers and patients, including through specialty drug, specialty and home infusion, skilled nursing, senior living, behavioral (intellectual and developmental disabilities and mental health), and hospital pharmacy solutions. For more information about Onco360, please visit Onco360.com.