Neal D. Shore, MD, FACS; and E. David Crawford, MD, presented “New Prescribing Information on Survival Benefit for Nubeqa® (Darolutamide) Approved” for the Grand Rounds in Urology audience in January 2021.

How to cite: Shore, Neal D. Crawford, E. David. “New Prescribing Information on Survival Benefit for Nubeqa® (Darolutamide) Approved” January 2021. Accessed May 2021. https://grandroundsinurology.com/new-prescribing-information-on-survival-benefit-for-nubeqa-darolutamide-approved/

Summary:

E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at the University of California, San Diego, interviews Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, about the recent FDA amendment to the package insert for NUBEQA®, or darolutamide. The amendment includes new information for patients with non-metastatic castration-resistant prostate cancer (nmCRPC) from the ARAMIS trial on overall survival and other endpoint data, including time to pain progression and time to the requirement for cytotoxic chemotherapy. Drs. Crawford and Shore discuss how the recent data demonstrating darolutamide’s overall survival benefit validates the previous use of metastasis-free survival as a surrogate for value. They also talk about the value of darolutamide for patients with nmCRPC who may not see much benefit to taking another medication. Drs. Crawford and Shore conclude by considering darolutamide’s future, mentioning the ARASENS trial looking at darolutamide’s benefits for patients with metastatic hormone-sensitive prostate cancer and discussing potential new research into darolutamide in the mCRPC space.