FDA Grants Priority Review to Nubeqa for Metastatic Prostate Cancer

By Emily Menendez - Last Updated: May 4, 2022

Bayer’s darolutamide drug, Nubeqa, in combination with docetaxel, has been granted priority review by the FDA to treat metastatic hormone-sensitive prostate cancer and has been accepted as a new prostate cancer indication. The new indication is based on the results of the randomized phase 3 ARASENS trial involving 1,306 men with newly-diagnosed metastatic hormone-sensitive prostate cancer. Researchers assigned patients to androgen deprivation therapy along with docetaxel and either 600 mg darolutamide twice daily or placebo.

The FDA approved Nubeqa to treat nonmetastatic castration-resistant prostate cancer in 2019 based on positive results from the phase 3 ARAMIS study; the main endpoint to determine efficacy was metastasis-free survival. According to a press release issued by Bayer, darolutamide is an androgen receptor (AR) inhibitor designed to inhibit androgen binding, AR nuclear translocations and AR-mediated transcription. Results presented at the 2022 ASCO Genitourinary Cancers Symposium showed that the addition of darolutamide to docetaxel and combined with androgen deprivation therapy decreased risk of death by 32.5%, and prolonged overall survival rate.

New Standard of Care

“Darolutamide in combination with ADT and docetaxel should become a new standard of care for treatment of [this patient population],” Matthew R. Smith, MD, PhD (Claire and John Bertucci endowed chair in genitourinary cancers at Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School) said during a presentation.

Prostate cancer is the second most common cancer diagnosed in men worldwide. At the time of diagnosis, many patients already have localized prostate cancer, meaning it may be curable with surgery or radiotherapy. However, upon relapse, the disease becomes hormone-sensitive, requiring the use of androgen deprivation therapy as the primary form of treatment. According to Matthew R. Zibelman, MD, a triple therapy of ADT, darolutamide and docetaxel should be first offered to patients with instances of de novo metastatic disease. Outside of this, men can be offered a combination of ADT and an androgen receptor-axis-targeted therapy, with docetaxel reserved for later lines of therapy.



FDA grants priority review to Nubeqa for metastatic prostate cancer

Addition of darolutamide to ADT, docetaxel prolongs OS in metastatic prostate cancer

FDA Accepts Bayer’s Application to Expand Nubeqa into New Prostate Cancer Indication