The Chinese National Medical Products Administration (NMPA) has greenlit Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), for use with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT. The combination was generally well tolerated and led to fewer treatment discontinuations due to adverse events.
Prostate cancer remains a major global health challenge, ranking as the second most common cancer in men and the fifth leading cause of cancer death worldwide. In 2022 alone, an estimated 1.5 million men were diagnosed, with nearly 400,000 deaths. In China, the burden is rising sharply, with projected 315,310 new cases and 81,540 deaths by 2030.
“mHSPC is a crucial treatment window to delay progression to poor prognosis mCRPC,” said Professor Xing Nianzeng of the Cancer Hospital, Chinese Academy of Medical Sciences.
“Over the past decade, the treatment for mHSPC has evolved from ADT alone to combination regimens. Darolutamide, new-generation androgen receptor inhibitor, is increasingly becoming standard therapy for mHSPC. Darolutamide plus ADT (with docetaxel in ARASENS) improves overall survival, and ARANOTE shows an effective darolutamide-based option without docetaxel for patients who cannot or will not receive chemotherapy.”
Christine Roth, Executive Vice President at Bayer, added: “The rising incidence of prostate cancer in China poses a serious threat to men’s health, and highlights that patients need personalized support. This third approval for darolutamide is supported by compelling clinical data from the ARANOTE trial which reaffirms its efficacy, safety and tolerability.
"Darolutamide can now be used with or without chemotherapy in China, offering physicians greater flexibility to tailor treatment plans to better meet the individual needs of patients, helping to improve clinical outcomes for men with mHSPC.”
With this approval, darolutamide plus ADT can be prescribed in China with or without docetaxel. Globally, Nubeqa is already approved in over 85 markets for mHSPC in combination with ADT and docetaxel, as well as for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).
Darolutamide is jointly developed by Bayer and Finland’s Orion Corporation, combining international expertise in prostate cancer treatment.
