FDA Approves Nubeqa Tablet Regimen for Metastatic Hormone-Sensitive Prostate Cancer

The Food and Drug Administration (FDA) approved Nubeqa (darolutamide) tablets plus the chemotherapy docetaxel for adults with metastatic hormone-sensitive prostate cancer, according to the agency.

The approval was based off findings from the ARASENS clinical trial that involved 1,306 patients with metastatic hormone-sensitive prostate cancer, who were randomly assigned to receive either oral Nubeqa plus docetaxel or placebo plus docetaxel. Additionally, all patients on the study received gonadotropin-releasing hormone analog alongside treatment or had a bilateral orchiectomy (removal of the testicles).

Average overall survival (time from treatment until death of any cause) was not reached for patients in the Nubeqa group because so many patients were still alive at the time of data collection, whereas it was 48.9 months in the docetaxel/placebo group. Additionally, patients given the Nubeqa-containing regimen had a significant delay in time time-to-pain progression, the FDA reported.

The average patient age on ARASENS was 67. At the time of enrollment, 3% had disease that spread to their distant lymph nodes, 83% had disease that spread to their bones and 14% had disease that spread to organs.

The most common side effects seen in patients treated with Nubeqa on the ARASENS trial were constipation, decreased appetite, rash, hemorrhage, weight gain and high blood pressure.

Common laboratory abnormalities, which appeared in 30% or more of patients, were anemia; high blood sugar; decreased lymphocyte or neutrophil (both types of white blood cell) counts; increased aspartate aminotransferase or alanine aminotransferase levels, which could indicate liver damage; and decreased calcium.

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