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Search jobs 08-Jan-2021 U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information
Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival (OS) compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer (nmCRPC) the opportunity to extend their lives
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Time to pain progression, a key secondary endpoint, is meaningful for men living with nmCRPC and an important consideration in treatment decisions
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WHIPPANY, N.J. (BUSINESS WIRE) Bayer today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to add overall survival (OS) and other secondary endpoint data from the Phase III ARAMIS trial to the NUBEQA