CHMP recommends darolutamide for the treatment of metastatic hormone-sensitive prostate cancer.- Bayer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
"Despite significant advances, for many men with mHSPC, disease progression and the onset of debilitating symptoms remain commonplace. It is therefore critical that these patients have access to treatment options that can not only improve mortality but also delay the time to symptom progression," said Prof. Bertrand Tombal, Professor of Urology at the Université catholique de Louvain (UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium. "The ARASENS trial is the first to demonstrate the benefits of darolutamide plus ADT in combination with docetaxel in both reducing the risk of death and minimizing deterioration in quality of life with similar overall incidence of adverse events between treatment arms.
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