Application submitted for third indication of darolutamide in the EU – Bayer

Bayer announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The compound is already approved in mHSPC, under the brand name Nubeqa in combination with ADT and docetaxel in over 80 markets around the world. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world.

“Each man with metastatic hormone-sensitive prostate cancer has unique needs. It’s crucial to equip physicians with options to tailor treatment plans to the individual, whether that is with or without chemotherapy,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Our ambition is to redefine what it means to live with prostate cancer at different stages of the disease, extending survival and delaying disease progression, while maintaining daily living.”

Results from the Phase III ARANOTE trial, on which this new submission is based, showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC.