Skip to Accessibility Tools Skip to Content Skip to Footer

FDA Approves Nubeqa to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer

The Food and Drug Administration (FDA) approved Nubeqa (darolutamide) to treat non-metastatic castration-resistant prostate cancer. The drug was approved under the FDA’s Priority Review designation, which is designed for drugs that significantly improve the safety or efficacy of various treatments.1

Treating castration-resistant prostate cancer

It is estimated that approximately more than 73,000 men will be diagnosed with castration-resistant prostate cancer (CRPC) in 2019.1 Castration-resistant prostate cancer continues to grow, even after the level of testosterone in the body is drastically reduced. Nearly half of these individuals (40%) have prostate cancer that has not spread to other parts of the body, making it non-metastatic. Their PSA level continues to rise, despite “castrate testosterone levels.” This is called non-metastatic castrate-resistant prostate cancer, or nmCRPC.1

Non-metastatic prostate cancer does not always remain contained. Almost a third of these men with nmCRPC will develop metastases, or see their cancer spread to other parts of the body, within 2 years, making diagnosis and PSA monitoring especially important.1 While many men with this type of prostate cancer often don’t have symptoms, treatment can delay the cancer’s spread and minimize the side effects of therapy.

What is Nubeqa?

Nubeqa is an androgen receptor inhibitor (ARi), which means it works to inhibit androgen hormones to slow down or stop cancer cell growth. The FDA approval is based on results from the Phase III ARAMIS trial, a multi-center, double-blind, placebo-controlled clinical trial where the drug was used with androgen deprivation therapy (ADT).

A closer look at the results

The results showed a highly significant improvement in metastasis-free survival (MFS): a median of 40.4 months, versus 18.4 months for placebo and ADT.1 Overall survival and time to pain progression were also improved with Nubeqa, although more time and research are needed to finalize overall survival results.

Robert LaCaze, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer, noted, “With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men living with nmCRPC.”1

The most common adverse reactions to the drug included fatigue, pain in the extremities, and rash.2 The recommended dose of Nubeqa is 600 mg, split into two 300 mg tablets, taken orally twice daily with food.2 Individuals taking Nubeqa should also be taking a gonadotropin-releasing hormone (GnRH) analog at the same time, or should have had a bilateral orchiectomy (both testicles removed).2

If you’re interested in seeing whether Nubeqa may be right for you, talk with your oncology treatment team.

What is Bayer’s DUDE program?

To ensure that those patients receiving Nubeqa have access to support throughout treatment, Bayer is launching an innovative patient support program, DUDE (Darolutamide User Drug Experience) Access Services™. This program offers a two-month Free Trial Program to eligible patients with a $0 co-pay for commercially insured patients who qualify. To learn more about the DUDE assistance program, visit Bayer’s website.

  1. FDA Approves Bayer’s Nubeqa (darolutamide), a New Treatment for Men with Non-Metastatic Castration-Resistant Prostate Cancer. Prostate Cancer Foundation. Published July 30, 2019. Accessed July 31, 2019.
  2. FDA Approves Darolutamide for Non-Metastatic Castration-Resistant Prostate Cancer. U.S. Food and Drug Administration. Published July 31, 2019. Accessed July 31, 2019.