Nubeqa Receives a New Indication, in Combination with Docetaxel, for Metastatic Hormone-Sensitive Prostate Cancer

On August 5, 2022, the FDA approved darolutamide (Nubeqa; Bayer) tablets, in combination with docetaxel, for the treatment of adult patients with metastatic hormone-sensitive prostate cancer. The FDA granted this new indication a priority review.

Darolutamide was previously approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

This new indication was approved based on the ARASENS study, a randomized, multicenter, double-blind, placebo-controlled clinical trial in 1306 patients with metastatic hormone-sensitive prostate cancer. Patients were randomized to darolutamide 600 mg orally twice daily plus intravenous docetaxel 75 mg/m2 every 3 weeks for up to 6 cycles or docetaxel plus placebo. All patients received a gonadotropin-releasing hormone analog concurrently or had a bilateral orchiectomy.

The primary efficacy measure was overall survival (OS). Time-to-pain progression was an additional efficacy measure. Median OS was not reached in the darolutamide plus docetaxel arm and was 48.9 months in the docetaxel plus placebo arm. Treatment with darolutamide and docetaxel also resulted in a statistically significant delay in time-to-pain progression.

The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common (≥30%) laboratory test abnormalities were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate aminotransferase, increased alanine aminotransferase, and hypocalcemia.

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