Breaking news: FDA approves darolutamide for hormone-sensitive metastatic prostate cancer

Today, the FDA approved darolutamide in combination with docetaxel chemotherapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC). This means that patients with mHSPC (prostate cancer that has spread beyond the prostate and is responding to hormone therapy, or who have not yet received hormone therapy) have an additional treatment option.

Darolutamide (Nubeqa) is a new hormone therapy that works by blocking the androgen receptor. Androgens are the hormones that act as the “fuel” for prostate cancer. The approval is based on the results of a large phase 3 clinical trial called ARASENS. This trial compared outcomes between 1,300 patients who received docetaxel + standard ADT + darolutamide versus patients who received docetaxel + standard ADT + placebo. 86% of patients were newly diagnosed with prostate cancer that had metastasized to bones or other organs.

Patients treated with the addition of darolutamide were 32% less likely to die during the study follow-up period compared with patients treated with docetaxel + ADT alone. These patients also had an improvement in time to castration resistance (when ” class=”glossaryLink “>PSA rises and the disease worsens, despite hormone therapy), time to pain progression, time to to skeletal-related symptomatic events (ie, bone fractures, need for bone radiation, etc.) and time to next cancer therapy.Importantly, these improved outcomes of intensification of triplet therapy was associated with only a modest increase in adverse events.

This approval provides further support for the growing evidence for “step-up” mHSPC therapy. “Doublet” therapy—the addition of docetaxel or a new, oral hormonal therapy (abiraterone, apalutamide, or enzalutamide) to ADT—is the current standard of care. Darolutamide + docetaxel + ADT is a “triple” therapy. Read more about treatment intensification in mHSPC here.

What this means for patients: If you are diagnosed with mHSPC, talk to your doctor about treatment beyond standard ADT. You have many treatment options. Research strongly supports and guidelines recommend adding a new, oral hormonal therapy OR docetaxel to ADT. Darolutamide + docetaxel + ADT is now FDA approved as an additional option.

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