Darolutamide for Castration-Resistant Prostate Cancer: FDA Updates Prescribing Info

The FDA has added new overall survival and other secondary outcome data to the prescribing information for darolutamide (Nubeqa®, Bayer), an androgen receptor inhibitor which was approved for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC) in 2019. The updates were based on the final analysis of the phase 3 ARAMIS trial (NCT02200614), led by first author Karim Fizazi, MD, Head of the Department of Cancer Medicine at the Institut Gustave Roussy in Villejuif, France. The...
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Darolutamide Approved in Nonmetastatic CRPC

The FDA has now approved darolutamide (Nubeqa®, Bayer), an androgen receptor antagonist, for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC). The approval was based on the ARAMIS phase 3 trial (NCT02200614), which enrolled 1,509 patients with nonmetastatic CRPC and a prostate-specific antigen doubling time of 10 months or less. Patients were randomized in a 2:1 ratio to receive darolutamide or placebo along with continued androgen deprivation therapy for a primary end ...
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