Finnish pharmaceutical company Orion Corporation (HEL:ORNBV) and German pharmaceutical and life sciences company Bayer AG (ETR:BAYN) (OTC:BAYRY) on Monday announced European Commission approval for darolutamide, an oral androgen receptor inhibitor (ARi), in combination with androgen deprivation therapy (ADT) to treat metastatic hormone-sensitive prostate cancer (mHSPC).

The decision is based on the Phase III ARANOTE trial, which showed a 46% reduction in the risk of radiological progression or death with darolutamide plus ADT compared to placebo plus ADT.

This approval expands the use of darolutamide, allowing physicians to tailor treatment plans using ADT with or without chemotherapy (docetaxel).

Darolutamide, marketed under the name Nubeqa, is already approved in over 85 countries for various prostate cancer indications, including non-metastatic castration-resistant prostate cancer. The drug is jointly developed by Orion and Bayer.

Prostate cancer remains a significant global health burden, with 1.5 million new cases and nearly 400,000 deaths reported in 2022. In Europe alone, there were an estimated 474,000 new cases and 115,000 deaths in 2022, with projections rising to 2.9 million diagnoses by 2040.