Nubeqa Prescribing Information Updated With New Survival Data

Nubeqa Prescribing Information Updated With New Survival Data
The prescribing information for Nubeqa (darolutamide) — used to treat men with prostate cancer that has not spread to other parts of the body — will be updated to include overall survival data for patients with non-metastatic castration-resistant prostate cancer (nmCRPC), according to Bayer, one of the therapy’s developers. Specifically, data demonstrating that Nubeqa lowers the risk of death by 31% in nmCRPC will now be included in the prescribing information, Bayer announced. In addition, other new information from key secondary endpoints of the ARAMIS Phase 3 trial (NCT02200614) will be added to the therapy’s prescribing information. This includes the fact that Nubeqa significantly delays the time to pain worsening, as well as the time to chemotherapy initiation, in these patients. All these changes to Nubeqa’s original prescribing information were made possible after the U.S. Food and Drug Administration (FDA) cleared a supplemental new drug application (sNDA) requesting the addition of these new findings. “Nubeqa has a proven efficacy and safety profile in men with nmCRPC and delayed the effects of disease progression in men who are otherwise generally asymptomatic,” Scott Z. Fields, MD, senior vice president and head of oncology development at Bayer, said in a press release. "This update also gives physicians added certainty that Nubeqa should be prescribed to appropriate patients at nmCRPC diagnosis to help ensure optimal outcomes for these men," Fields said. Jointly developed by Bayer and Orion Pharma, Nubeqa is an oral medication that works by blocking the activity of androgen receptors — proteins found on the surface of cells that bind to male hormones — and interrupting a signaling cascade that is known to promote prostate
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