Nubeqa (darolutamide) receives EU approval for additional indication in prostate cancer
The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nubeqa is already approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
“Today’s approval of Nubeqa represents a significant milestone in addressing unmet medical needs for people living with metastatic hormone-sensitive prostate cancer in Europe,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. “We are committed to improving prostate cancer care across all stages of the disease and recognize that for patients and their families, quality of life is just as critical as prolonging survival and delaying disease progression. We continue in our mission to redefine what it means to live with prostate cancer.”
The EU approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus ADT in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with 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.
“The approval of Nubeqa in mHSPC in Europe is a major step forward for patients and their treating physicians, expanding the treatment options available and our ability to improve clinical outcomes for those living with the disease,” said Prof. Bertrand Tombal, Professor of Urology at the Université catholique de Louvain (UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium. “This approval is supported by robust data from the ARASENS clinical trial, which demonstrate the benefits of darolutamide plus ADT in combination with docetaxel in extending survival, delaying disease progression and maintaining quality of life for patients with metastatic hormone-sensitive prostate cancer.”
Prostate cancer is the most commonly diagnosed cancer in men in almost all northern and western European countries.1
Only 30% of men with mHSPC will survive five years or more after diagnosis.2 Most men with mHSPC eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited long-term survival.3,4
Nubeqa is being investigated in a broad development program with an additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes the ARANOTE Phase III trial evaluating darolutamide and ADT versus ADT alone for mHSPC.
Nubeqa is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Bayer is responsible for global commercialization, with co-promotion from Bayer and Orion Corporation in certain European markets, e.g. France, Germany, Italy, Spain, the UK, Scandinavia and Finland.