Posted from: Thursday, September 19, 2019 - 09:35 AM - Present

Nubeqa Approved to Treat Prostate Cancer

July 30, 2019 – The U.S. FDA has approved Nubeqa® (darolutamide) tablets, manufactured by Bayer, to treat non-metastatic, castration-resistant prostate cancer (nmCRPC).

An estimated 73,000 men in the United States are expected to be diagnosed with castration-resistant prostate cancer (CRPC) in 2019. Approximately 40% of CRPC patients have nmCRPC (cancer that has not spread to other parts of the body), with one-third expected to develop metastatic disease within two years. The primary treatment goals for nmCRPC are to delay the spread of the disease while limiting the burden of treatment side effects.

In a clinical study, Nubeqa plus androgen deprivation therapy (ADT) produced a median metastasis-free survival (MFS) time of 40.4 months compared to 18.4 months with placebo plus ADT. Nubeqa also delayed time to pain progression, defined as either the initiation of opioid therapy or at least a 2-point worsening from baseline as measured by the Brief Pain Inventory-Short Form.

Recommended dosing is 600mg (two 300mg tablets) taken orally twice per day with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or have already had a bilateral orchiectomy.

Nubeqa has launched at a wholesale acquisition cost (WAC) of $11,550 for a one-month supply.

Last Updated Friday, October 18, 2019 - 12:31 AM.