Posted by Michael Wonder on 22 Jul 2025
Bayer’s Nubeqa (darolutamide) receives EU approval in third indication for patients with advanced prostate cancer
21 July 2025 - Approval is based on positive results from the pivotal Phase 3 ARANOTE trial and reinforces darolutamide’s established efficacy, safety and tolerability profile for prostate cancer patients across all approved indications.
The European Commission has granted marketing authorisation in the European Union for Nubeqa (darolutamide), an oral androgen receptor inhibitor, plus androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.
