The FDA approves Nubeqa (Bayer), an androgen receptor inhibitor (ARI), for non-metastatic castration-resistant prostate cancer (nmCRPC).
The approval is based on the phase 3 ARAMIS clinical trial that evaluated darolutamide plus androgen deprivation therapy (ADT). Patients taking darolutamide showed highly significant improvement in metastasis-free survival––the primary efficacy endpoint––with a median of 40.4 months compared to 18.4 months for placebo plus ADT.
It is estimated that 73,000 men will be diagnosed with castration-resistant prostate cancer in the United States this year. Of that number, approximately 40% will have cancer that hasn’t spread to other parts of the body and is associated with a rising prostate-specific antigen (PSA) level, despite a castrate testosterone level, known as nmCRPC.
Approximately one-third of men with nmCRPC go on to develop metastases within two years.
In ARAMIS, both trial arms showed a 9% discontinuation rate from adverse side effects. The most common adverse reaction requiring discontinuation included cardiac failure (0.4%) and death (0.4%). More frequent side effects in the Nubeqa arm were fatigue, pain in extremities, and rash. Read Data from trials
About Food and Drug Administration (FDA)
The Food and Drug Administration is one of the nation’s oldest and most respected consumer protection agencies. This presentation will tell you about FDA’s responsibilities, the tools we use to fulfill those responsibilities, and our priorities for improving the way we serve the public.
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FDA’s Mission Statement
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