US FDA approves additional indication of darolutamide in combination with docetaxel

The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral Androgen Receptor inhibitor (ARi) darolutamide in combination with docetaxel by Bayer for the treatment of patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Bayer informed via a statement.

The statement noted that the approval is based on positive results of the phase-III Arasens trial that demonstrated darolutamide plus Androgen Deprivation Therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5 per cent compared to ADT plus docetaxel. The results were recently published in The New England Journal of Medicine.

Darolutamide is approved in more than 70 markets around the world, including the US, the European Union (EU), Japan and China, 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. The compound is also being investigated in further studies across various stages of prostate cancer, the statement added.

The application received Priority Review designation granted by the FDA and was submitted under the FDA’s Real-Time Oncology Review (RTOR) pilot programme, which aims to provide a more efficient review process of applications to ensure that safe and effective cancer treatments are available to patients as early as possible. Ongoing reviews are also being conducted under the FDA Oncology Centre of Excellence’s (OCE) Project Orbis initiative, which provides a framework for concurrent submission and review of cancer treatments among participating international health authorities.

Darolutamide is developed jointly by Bayer and Orion Corporation, concluded the statement.