Nubeqa approved for metastatic hormone-sensitive prostate cancer in China.- Orion Corporation + Bayer

Nubeqa is already approved in China for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

"Prostate cancer cases in China have increased significantly in recent years. Compounding that, nearly a third of patients who are newly diagnosed will have metastatic disease. We are therefore delighted that patients in China will now have a new treatment option for metastatic hormone-sensitive prostate cancer that delays disease progression, extends survival and maintains quality of life", said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology SBU at Bayer. "Bayer is committed to improving health outcomes for people living with prostate cancerand that as many eligible patients as possible gain access to Nubeqa."

The approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms. These results were published in The New England Journal of Medicine.(previously cited) .