FDA approves Darolutamide for metastatic castration-sensitive prostate cancer
FDA approves darolutamide for metastatic castration-sensitive prostate cancer on june 3, 2025. Darolutamide is currently manufactured by the Bayer Healthcare Pharmaceuticals Inc. under the name of NUBEQA®. Previoulsy darolutamide was approved in combination with docetaxel for the treatment of metastatic castration-sensitive prostate cancer (mCSPC).
- Available potency: 300mg tablet
- Recommended Dose : 600mg (two 300mg tablets) taken orally, twice daily, with food
Prostate cancer is one of the most common cancer in men and metastatic prostate cancer has become the second most common cause of cancer associated deaths in men in united states.
Prostate cancer that requires androgens (male hormones) for its growth and therefore stops growing when the patient become deprived of androgen. so, decreasing the amount of androgens in the body or antagonizing their action may be an effective type of therapy for such cancers. Thus the prostate cancers that stop growing or decrease their growth rate due to the absence of androgen hormone are known as castration-sensitive prostate cancer (CSPC). Such cancers are also known as androgen-dependent prostate cancer, androgen-sensitive prostate cancer, hormone-sensitive prostate cancer, and HSPC.
Darolutamide is an androgen receptor blocker that blocks the action of androgen hormone and consequently decreases the growth rate of metastatic castration sensitive prostate cancer and increase the survival rate of the patient.
The efficacy and safety trials information is available at FDA.
References:
U.S. Food and Drug Administration. (2025, June 3). FDA approves darolutamide for metastatic castration-sensitive prostate cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer
National Cancer Institute. (n.d.). Castrate-sensitive prostate cancer. National Institutes of Health. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/castrate-sensitive-prostate-cancer
National Cancer Institute. (2021, February 25). Hormone therapy for prostate cancer. National Institutes of Health. https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet
Hahn, A. W., Higano, C. S., Taplin, M.-E., Ryan, C. J., & Agarwal, N. J. A. S. C. O. E. B. (2018). Metastatic castration-sensitive prostate cancer: optimizing patient selection and treatment. 38(38), 363-371.
