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Darolutamide for Castration-Resistant Prostate Cancer: FDA Updates Prescribing Info

Prostate cancer cells.

The FDA has added new overall survival and other secondary outcome data to the prescribing information for darolutamide (Nubeqa®, Bayer), an androgen receptor inhibitor which was approved for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC) in 2019.

The updates were based on the final analysis of the phase 3 ARAMIS trial (NCT02200614), led by first author Karim Fizazi, MD, Head of the Department of Cancer Medicine at the Institut Gustave Roussy in Villejuif, France. The trial randomized 1,509 patients with nonmetastatic CRPC in a 2:1 ratio to darolutamide or placebo, both in combination with androgen deprivation therapy (ADT). The primary end point was metastasis-free survival, with secondary end points including overall survival, time to pain progression, and time to initiation of cytotoxic chemotherapy. Primary analyses found that patients receiving darolutamide experienced a significantly longer median metastasis-free survival compared with placebo (40.4 vs 18.4 months).

According to the final analysis, performed at a median follow-up of 29 months, darolutamide produced a higher three-year overall survival rate compared with placebo (83% vs 77%), with a 31% lower risk of death. The increase in overall survival was considered statistically significant, despite 31% of patients in the placebo plus ADT group crossing over to receive darolutamide. Patients receiving darolutamide experienced a significantly delayed median time to pain progression (40.3 vs 25.4 months) compared with placebo. Additionally, darolutamide was associated with a reduced time to initiation of cytotoxic chemotherapy, with 83% of patients not requiring chemotherapy compared with 75% of those in the placebo group.

No new safety signals were identified at the time of the final analysis. The prescribing information was updated with a warning that darolutamide inhibits OATP1B1 and OATP1B3 transporters, which may increase plasma concentrations of OATP1B1/OATP1B3 substrates if used concurrently. Patients receiving these drugs concomitantly with darolutamide should be monitored for adverse events, with dose reduction if needed.

"Among men with nonmetastatic CRPC, the percentage of patients who were alive at three years was significantly higher among those who received darolutamide than among those who received placebo," concluded Dr. Fizazi and colleagues in their publication of the final results in the New England Journal of Medicine in September 2020. "The incidence of adverse events was similar in the two groups."

For More Information

Fizazi K, Shore N, Tammela TL, et al (2020). Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med, 383:1040-1049. DOI:10.1056/NEJMoa20013432

Clinicaltrials.gov (2021). Efficacy and safety study of darolutamide (ODM-201) in men with high-risk nonmetastatic castration-resistant prostate cancer (ARAMIS). NLM identifier: NCT02200614.

Nubeqa® (darolutamide) prescribing information (2021). Bayer. Available at: http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf

Cancer Network (2021). FDA adds new data to label for darolutamide in nmCRPC. Available at: https://www.cancernetwork.com/view/fda-adds-new-data-to-label-for-darolutamide-in-nmcrpc

Image credit: Nephron. Licensed under CC BY-SA 4.0


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