EU approves Nubeqa for hormone-sensitive prostate cancer
The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi) from Bayer and Orion Corp, plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Nubeqa is already approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
The EU approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus ADT in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with mHSPC. Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
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