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 Dec 2024. https://dev.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.
ABOUT THE AUTHOR
Neal D. Shore, MD, FACS, is the Medical Director for the Carolina Urologic Research Center. He practices with Atlantic Urology Clinics in Myrtle Beach, South Carolina.
Dr. Shore has conducted more than 350 clinical trials, focusing mainly on genitourinary oncology, and serves on the executive boards of the Society of Urologic Oncology and the Bladder Cancer Advocacy Network. He is Past President of the Large Urology Group Practice Association. He is a founder for both CUSP Clinical Trials Consortium and DASHKO, a national urology practice data registry. He serves as the National Urology Research Director for 21st Century Oncology. He has served on the AUA Male Health Committee and the AUA Data Committee, the SITC Task Force for Prostate Cancer, the Bladder Cancer Advocacy Think Tank, and the Editorial Boards of Review in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, and World Journal of Urology. He serves as Editor of Everyday Urology-Oncology. Dr. Shore has written more than 200 peer-reviewed publications and numerous book chapters. He performs peer review for Lancet Oncology, New England Journal of Medicine, European Urology, the Journal of Urology, Urology, BJUI, PCPD, and numerous other high-impact scientific journals.
A graduate of Duke University and Duke University Medical School, Dr. Shore completed a 6-month clinical research fellowship in Pretoria, South Africa, and then completed his General Surgery/Urology training at New York Hospital Cornell Medical Center and at Memorial Sloan-Kettering Cancer Center in New York City. He is a Fellow of the American College of Surgeons.
