New Treatment For Men With Non-Metastatic Castration-Resistant Prostate Cancer Approved by U.S. FDA

A doctor talking to a patient in a hospital bed.

The U.S. Food and Drug Administration (FDA) has approved a new, unique androgen receptor inhibitor (ARi) that delays metastases and extends survival, while minimizing additional side effects of therapy, allowing patients with non-metastatic castration-resistant prostate cancer (nmCRPC) to maintain their current lifestyle.1

With this approval, physicians will have a new therapeutic option that significantly extends metastasis-free survival, with a favorable safety profile compared to placebo plus androgen deprivation therapy (ADT).1


What the approval in the U.S. means for patients

Despite recent advances in nmCRPC treatment, there remains a high unmet need for new options that not only delay the time to metastases, but also limits the sometimes burdensome side effects of 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.2 In the U.S., over 73,000 men are estimated to have a CRPC diagnosis in 2019.3 About one-third of men with non-metastatic CRPC go on to develop metastases within two years.4

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1 Nubeqa® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, [month] 2019.

2 Luo, Jia, Beer, Tomasz, Graff, Julie. Treatment of nonmetastatic castration-resistant prostate cancer. Oncology 2016;30(4):336-44.

3 Bayer internal calculation based on Tesselon data (February 2018).

4 National Cancer Institute. Hormone Therapy for Prostate Cancer. Accessed July 2019.