FDA Approves NUBEQA® for Metastatic Castration-Sensitive Prostate Cancer

WHIPPANY, NJ, USA, June 03, 2025 – Bayer has announced a significant milestone in the treatment of prostate cancer, as the U.S. Food and Drug Administration (FDA) has approved NUBEQA® (darolutamide), an oral androgen receptor inhibitor (ARi), for adult patients dealing with metastatic castration-sensitive prostate cancer (mCSPC), also recognized as metastatic hormone-sensitive prostate cancer (mHSPC). This approval comes from the promising outcomes observed in the pivotal Phase III ARANOTE trial, where NUBEQA, combined with androgen deprivation therapy (ADT), exhibited a substantial 46% reduction in the risk of radiographic progression or death (rPFS) compared to placebo with ADT.

The ARANOTE trial, a randomized, double-blind, placebo-controlled study, aimed to evaluate the safety and effectiveness of combining NUBEQA with ADT for patients with mCSPC. The trial involved 669 participants, who were assigned in a 2:1 ratio to receive either 600 mg of NUBEQA (446 patients) or a placebo (223 patients), administered twice daily alongside ADT. In the United States, NUBEQA is now approved for treating adult patients with mCSPC, with or without the inclusion of docetaxel, as well as for those with non-metastatic castration-resistant prostate cancer (nmCRPC).

Dr. Fred Saad, the principal investigator of the ARANOTE trial and a prominent figure in genitourinary oncology, expressed optimism about the new regimen supported by clinical data. He emphasized that NUBEQA combined with ADT demonstrated remarkable efficacy in treating men with mCSPC. This recent FDA approval broadens the therapeutic options for physicians, providing them with another potential choice for handling prostate cancer cases.

Prostate cancer remains a prevalent health concern, ranking as the second most common cancer among men and the fifth leading cause of cancer-related death globally. In 2020, approximately 1.4 million men worldwide were diagnosed with prostate cancer, including nearly 300,000 cases in the United States, resulting in around 375,000 fatalities globally. Forecasts indicate that prostate cancer diagnoses could surge to 2.9 million worldwide by 2040.

Christine Roth, Bayer's Executive Vice President of Global Product Strategy and Commercialization, highlighted the significance of this approval, stating that robust clinical data reaffirm NUBEQA's role as a vital therapy for prostate cancer. She underscored Bayer's commitment to delivering meaningful outcomes for patients and their families, expressing gratitude to the scientists, doctors, and patients who contributed to this new treatment option's development.

The Phase III ARANOTE trial results, presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology, demonstrated consistent radiographic progression-free survival (rPFS) across various subgroups. Among patients with high-volume mCSPC, NUBEQA combined with ADT led to a 40% risk reduction, while those with low-volume disease experienced a 70% risk reduction. The safety profile of NUBEQA was consistent with established expectations, with similar rates of serious adverse events between the treatment groups. The discontinuation rate due to treatment-emergent adverse events was 6% for patients receiving NUBEQA plus ADT, compared to 9% for those receiving placebo plus ADT.

The ARANOTE trial underscored the efficacy and safety of NUBEQA combined with ADT, focusing on the primary endpoint of radiographic progression-free survival (rPFS), which measured the time from randomization to the first documented radiographic progression or death due to any cause.

NUBEQA® (darolutamide), developed in collaboration between Bayer and Orion Corporation, a Finnish pharmaceutical company, is an androgen receptor inhibitor designed to inhibit androgen binding, AR nuclear translocation, and AR-mediated transcription. With this approval, Bayer reinforces its commitment to advancing prostate cancer treatment and improving patient outcomes through innovative solutions.