On August 5, 2022, the FDA approved Nubeqa (darolutamide; from Bayer Healthcare), an androgen receptor inhibitor, for use with chemotherapy (docetaxel), for the treatment of men with metastatic (spreading) hormone-sensitive prostate cancer. Nubeqa was previously approved for men with nonmetastatic castration-resistant prostate cancer.
“Nubeqa plus ADT [androgen-deprivation therapy] and docetaxel has shown significant benefit in overall survival and a favorable safety profile for patients with metastatic hormone-sensitive prostate cancer,” said Matthew Smith, MD, PhD, Massachusetts General Hospital Cancer Center.
The approval of this new indication was based on results of the randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial that included 1306 men with metastatic hormone-sensitive prostate cancer.
Many of the patients who received Nubeqa in the study have continued to respond to the treatment after the study was over. By contrast, the average time of survival was about 4 years (48.9 months) in men who received placebo plus chemotherapy, meaning that their tumor stopped responding to the treatment.
The most common side effects reported in 10% or more of the men were constipation, decreased appetite, rash, bleeding, weight gain, and elevated blood pressure. Abnormal blood tests were reported for more than 30% of the patients.
