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Breaking News: FDA Approves Darolutamide for Metastatic Hormone-Sensitive 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 responsive to hormone therapy, or who have not yet received hormone therapy) have an additional treatment option.

Darolutamide (Nubeqa) is a novel hormone therapy that works by blocking the androgen receptor. Androgens are the hormones that act as prostate cancer’s “fuel.” The approval is based on the results of a large Phase 3 clinical trial called ARASENS. This trial compared outcomes among 1300 patients who received docetaxel + standard ADT + darolutamide vs. patients who received docetaxel + standard ADT + placebo. 86% of the patients were newly diagnosed with prostate cancer that had metastasized to the bones or other organs.

Patients treated with the addition of darolutamide were 32% less likely to die during the study follow-up period compared to patients treated with docetaxel + ADT alone. These patients also had improved time to castration resistance (when the PSA increases and disease worsens, despite hormone therapy), time to pain progression, time to symptomatic skeletal related events (i.e., bone fractures, needing radiation to the bones, etc.), and time to next cancer therapy. Importantly, these improved outcomes of triplet therapy intensification were associated with only a modest increase in adverse events.

This approval provides further support to the growing evidence for “intensified” therapy of mHSPC. “Doublet” therapy—the addition of docetaxel or an oral, novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) to ADT—is the current standard of care. Darolutamide + docetaxel + ADT is “triplet” therapy. In this press release announcing the news, PCF CEO Dr. Charles J. Ryan notes that “this approval adds a different treatment approach for mHSPC patients and their physicians to choose from.”

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 alone. You have many treatment options. Research strongly supports, and guidelines recommend adding an oral, novel hormonal therapy OR docetaxel to ADT. Now, darolutamide + docetaxel + ADT is FDA-approved as an additional option.

Becky Campbell
Becky Campbell develops medical content at the Prostate Cancer Foundation. She has previously worked in outcomes research and in science education.