FDA accepts NDA and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer.
Bayer announced the FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).
The application is being conducted under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative, which provides a framework for concurrent submission and review of cancer treatments among participating international health authorities.
The sNDA is based on positive results from the pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival (OS) for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC compared to ADT plus docetaxel, which were published in The New England Journal of Medicine.
Darolutamide is already approved in more than 60 markets around the world, including the U.S., 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.
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