FDA approves darolutamide for metastatic prostate cancer subset

August 05, 2022

1 min read

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The FDA approved darolutamide tablets in combination with docetaxel for men with metastatic hormone-sensitive prostate cancer.

Darolutamide (Nubeqa, Bayer) is an androgen receptor (AR) inhibitor designed to inhibit androgen binding, AR nuclear translocation and AR-mediated transcription.

4-year OS results
Data derived from Smith MR, et al. Abstract 13. Presented at: ASCO Genitourinary Cancers Symposium; Feb. 17-19, 2022; San Francisco.

The FDA based the approval on results of the randomized phase 3 ARASENS trial, which included 1,306 men with newly diagnosed metastatic hormone-sensitive prostate cancer.

Researchers assigned men to androgen deprivation therapy and docetaxel plus either 600 mg darolutamide twice daily or placebo.

OS served as the primary endpoint.

As Healio previously reported, results presented at ASCO Genitourinary Cancers Symposium and published in The New England Journal of Medicine showed the addition of darolutamide to ADT and docetaxel significantly extended OS (HR = 0.68; 95% CI, 0.57-0.8). Darolutamide-treated men also achieved prolonged time to pain progression (HR = 0.79; 95% CI, 0.66-0.95) .

The most common adverse events reported among men treated with darolutamide included constipation, decreased appetite, rash, hemorrhage, increased weight and hypertension. Laboratory test abnormalities that occurred among at least 30% of darolutamide-treated men included anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased aspartate aminotransferase and alanine aminotransferase levels, and hypocalcemia.

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