The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is already approved under the brand name Nubeqa™ for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

“This positive CHMP opinion underscores darolutamide’s potential to set a new standard of care for eligible patients living with prostate cancer,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology Strategic Business Unit. “With darolutamide’s unprecedented survival data and minimal disruption to patients´ daily living across both mHSPC and high risk nmCRPC, following regulatory approval, we will be working to ensure that as many patients as possible benefit from darolutamide. This recommendation is another step in our mission to redefine what it means to live with prostate cancer across various stages of the disease.”

“Despite significant advances, for many men with mHSPC, disease progression and the onset of debilitating symptoms remain commonplace. It is therefore critical that these patients have access to treatment options that can not only improve mortality but also delay the time to symptom progression," said Prof. Bertrand Tombal, Professor of Urology at the Université catholique de Louvain (UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium. “The ARASENS trial is the first to demonstrate the benefits of darolutamide plus ADT in combination with docetaxel in both reducing the risk of death and minimizing deterioration in quality of life with similar overall incidence of adverse events between treatment arms.”

The final decision from the European Commission on the marketing authorization is expected in the coming months. The compound is already approved in its second indication, mHSPC, in a number of markets including the U.S. under the brand name Nubeqa. Filings in other regions are underway or planned. Darolutamide is being investigated in a broad development program with 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 plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

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

Darolutamide 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.