CHMP recommends third indication for darolutamide for patients with advanced prostate cancer

Core Insights - The European Medicines Agency's CHMP has recommended darolutamide, an oral androgen receptor inhibitor, for marketing authorization in the EU for treating metastatic hormone-sensitive prostate cancer (mHSPC) [2][8] - The recommendation 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 when darolutamide was combined with androgen deprivation therapy (ADT) compared to placebo [2][7] - Darolutamide is already approved in over 85 countries and is the first FDA-approved ARi for mHSPC in the US [3] Industry Context - Prostate cancer is the second most common cancer and the fifth leading cause of cancer death among men globally, with an estimated 1.5 million diagnoses and 397,000 deaths in 2022 [4] - Prostate cancer diagnoses are projected to rise to 2.9 million by 2040, indicating a growing market for effective treatments [4] Clinical Trial Details - The ARANOTE trial involved 669 patients and was designed to assess the efficacy and safety of darolutamide plus ADT [5] - The primary endpoint was radiological progression-free survival (rPFS), with secondary endpoints including overall survival and time to first castration-resistant event [6] Treatment Implications - The CHMP's positive opinion allows for greater flexibility in treatment plans for mHSPC patients, enabling the use of darolutamide with or without chemotherapy [8] - Darolutamide has shown a favorable side effect profile, with adverse events comparable to placebo, making it a viable treatment option [10] Ongoing Research - A robust clinical development program is in place for darolutamide, including trials for high-risk biochemical recurrence prostate cancer and localized prostate cancer in combination with radiotherapy [11]