FDA grants priority review to Nubeqa for metastatic prostate cancer
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The FDA granted priority review to darolutamide in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer.
Darolutamide (Nubeqa, Bayer) is an androgen receptor (AR) inhibitor designed to inhibit androgen binding, AR nuclear translocation and AR-mediated transcription, according to a Bayer-issued press release.
The agent is approved in the United States for treatment of men with nonmetastatic castration-resistant prostate cancer.
A supplemental new drug application for the new indication is based on the randomized phase 3 ARASENS trial, which included 1,306 men with newly diagnosed metastatic hormone-sensitive prostate cancer.
Researchers assigned men to androgen deprivation therapy and docetaxel plus either 600 mg darolutamide twice daily or placebo.
OS served as the primary endpoint.
As Healio previously reported, results presented at ASCO Genitourinary Cancers Symposium and published in The New England Journal of Medicine showed the addition of darolutamide to ADT and docetaxel significantly extended OS.
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