The FDA has approved Bayer’s oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC). The approval was based on results from the Phase III ARANOTE trial, in which Nubeqa plus androgen deprivation therapy (ADT) demonstrated a notable reduction in the risk of radiographic progression or death compared to ADT plus placebo.¹

How Did Nubeqa Perform in Clinical Trials for Metastatic Castration-Sensitive Prostate Cancer?

“Clinical data from the ARANOTE trial supporting this new regimen showed that Nuqeba plus ADT demonstrated powerful efficacy in men with mCSPC,” said Fred Saad, MD, professor, chairman of surgery, director of genitourinary oncology, University of Montreal Hospital Center (CHUM), principal investigator of the ARANOTE trial, in a press release. “Today’s approval further expands physicians’ options for using Nuqemba with and without docetaxel in this setting, providing a potential new choice for patients.”

ARANOTE Trial Design

· The randomized, double-blind, placebo-controlled ARANOTE trial evaluated the efficacy and safety of Nubeqa in combination with ADT in 669 patients with mCSPC.

· Patients were randomly assigned in a 2:1 ratio to receive either 600 mg of Nubeqa or placebo plus ADT.

· The primary endpoint of the study was radiographic progression-free survival (rPFS), measured as the time from randomization to the first documented instance of radiographic progression or death from any cause.

Risk Reduction with Nubeqa Across Disease Volume Subgroups

· Results showed that Nubeqa demonstrated a 46% reduction in the risk of radiographic progression or death when combined with ADT.

· In patients with high-volume mCSPC, Nubeqa plus ADT demonstrated a 40% risk reduction, which increased to 70% among patients with low-volume disease.

Safety and Tolerability of Nubeqa

· Rates of serious adverse events (AEs) were similar between the two arms, with AEs occurring in approximately 24% of patients across both cohorts.

· Six percent of patients in the treatment group discontinued therapy due to treatment-related AEs, compared to 9% in the placebo group.

· These results were consistent with Nubeqa’s established safety profile.

Competitive Landscape in mCSPC Therapies

The approval comes as multiple pharmaceutical companies race to bring forward new therapies for mCSPC. This week, Johnson & Johnson announced promising data from the Phase III AMPLITUDE trial evaluating niraparib plus abiraterone acetate and prednisone—the first PARP inhibitor combination to show success in treating mCSPC.²

Prostate Cancer Trends and Disease Burden

According to Bayer, prostate cancer is the second most common form of cancer in men and the fifth leading cause of cancer death among men globally. Projections estimate that global prostate cancer diagnoses will rise to 2.9 million by 2040.¹

According to the American Cancer Society, approximately 313,780 new cases of prostate cancer are expected in the U.S. by the end of 2025, with an estimated 35,770 deaths. Despite this, nearly 3.5 million men diagnosed with prostate cancer at some point in their lives are currently still alive. From 1993 to 2022, the prostate cancer death rate declined by nearly 50%, largely due to earlier detection and improved treatments. However, in recent years, this decline has slowed, likely due to a rise in diagnoses at more advanced stages.³

Company Perspective on FDA Approval

“This approval, which is supported by strong clinical data, reaffirms Nuqemba as an important therapy for men with prostate cancer and underscores our commitment to delivering meaningful outcomes for patients and their families,” Christine Roth, executive vice president, Global Product Strategy and Commercialization and member of the Pharmaceuticals Leadership Team at Bayer, said in the release. “We thank the scientists, doctors, patients and their families who made it possible to provide this new treatment option for metastatic castration-sensitive prostate cancer.”

References

1. U.S. FDA Approves NUBEQA® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer. BusinessWire. June 3, 2025. Accessed June 4, 2025. https://www.businesswire.com/news/home/20250603153384/en/U.S.-FDA-Approves-NUBEQA-darolutamide-to-Treat-Patients-with-Metastatic-Castration-Sensitive-Prostate-Cancer

2. Johnson & Johnson’s PARP Inhibitor Combo Shows Significant Progression-Free Survival Benefit in BRCA-Positive mCSPC. PharmExec. June 4, 2025. Accessed June 4, 2025. https://www.pharmexec.com/view/johnson-johnson-parp-inhibitor-combo-significant-progression-free-survival-benefit-brca-positive-mcspc

3. Key Statistics for Prostate Cancer. American Cancer Society. Accessed June 4, 2025. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html