Darolutamide receives EU approval in third indication for patients with advanced prostate cancer

Core Insights - The European Commission has granted marketing authorization for darolutamide, an oral androgen receptor inhibitor, in combination with androgen deprivation therapy for the treatment of metastatic hormone-sensitive prostate cancer [2][8] - The approval is based on the positive results from the Phase III ARANOTE trial, which demonstrated a 46% reduction in the risk of radiological progression or death compared to placebo [2][7] Company Overview - Darolutamide, marketed as Nubeqa®, is developed jointly by Orion and Bayer and is already approved in over 85 countries for various indications related to prostate cancer [3][8] - Orion Corporation is a Nordic pharmaceutical company with a focus on oncology and pain management, employing approximately 3,700 professionals and generating net sales of EUR 1,542 million in 2024 [15][17] Industry Context - Prostate cancer is the second most common cancer among men globally, with an estimated 1.5 million new cases diagnosed in 2022 and projected to rise to 2.9 million by 2040 [4] - The ARANOTE trial involved 669 patients and aimed to assess the efficacy and safety of darolutamide plus ADT, with the primary endpoint being radiological progression-free survival [5][6]