Breaking News: FDA Approves Darolutamide for Metastatic Hormone-Sensitive Prostate Cancer
The FDA has approved darolutamide 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 newer form of hormone therapy known as an androgen receptor pathway inhibitor (ARPI) that works by blocking the androgen receptor. Androgens are the hormones that act as prostate cancer’s “fuel.” Darolutamide was first FDA-approved for mHSPC in 2022 in combination with docetaxel chemotherapy; this latest approval means that chemotherapy is not required.
The approval is based on the results of a large Phase 3 clinical trial called ARANOTE. This trial compared outcomes among 669 patients who received standard androgen deprivation therapy (ADT) + darolutamide vs. patients who received standard ADT + placebo. 72% of the patients were newly diagnosed with metastatic disease. The trial population was quite diverse, including about 30% Asian and 10% Black participants.
Patients treated with the addition of darolutamide were 46% less likely to have their disease progress on scans or to die vs. patients treated with ADT alone. Darolutamide delayed time to developing hormone resistance and worsening pain vs. ADT alone. Patients treated with darolutamide maintained their quality of life for an average of 5 months longer. Side effects associated with treatment were similar in both groups. Fatigue was lower in patients receiving darolutamide (5.6%) vs. those receiving placebo (8.1%). Fewer patients receiving darolutamide (6.1%) vs. placebo (9.0%) discontinued treatment because of side effects.
What this means for patients: This approval adds to the multiple treatment options already approved for metastatic hormone-sensitive prostate cancer. Talk to your doctor about which treatment is best for you.