Bayer announced that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor, NUBEQA (darolutamide), for the treatment of adult patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The FDA’s decision is based on data from the pivotal Phase III ARANOTE trial, which showed that NUBEQA, in combination with androgen deprivation therapy (ADT), significantly reduced the risk of radiographic progression or death by 46% compared to placebo plus ADT (hazard ratio: 0.54; 95% CI 0.41-0.71; p<0.0001).
The ARANOTE study was a randomized, double-blind, placebo-controlled trial involving 669 men with mCSPC. Participants received either NUBEQA (600 mg twice daily) plus ADT or placebo plus ADT. The treatment showed consistent benefit across subgroups, including a 40% risk reduction in high-volume disease and a 70% reduction in low-volume disease.
“This approval, supported by strong clinical data, reaffirms NUBEQA as an important therapy for men with prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer. “It expands treatment options for patients with or without prior chemotherapy.”
Prostate cancer remains a major global health burden, being the second most common cancer in men and a leading cause of cancer death. In 2020, nearly 300,000 U.S. men were diagnosed with prostate cancer, and global incidence is expected to rise to 2.9 million by 2040.
The safety profile of NUBEQA was consistent with previous findings, with similar rates of serious adverse events (24%) in both treatment and placebo groups. Discontinuation due to side effects was slightly lower in the NUBEQA group (6% vs. 9%).
With this expanded indication, NUBEQA is now approved in the U.S. for both mCSPC (with or without docetaxel) and non-metastatic castration-resistant prostate cancer (nmCRPC), offering a broader range of treatment strategies for clinicians and patients alike.