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://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, graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Kettering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center and is the Chief Medical Officer, Strategic Growth and Pharmacy, GenesisCare, US.
Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored or coauthored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, Maple Tree Alliance, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy for the Large Urology Group Practice Association (LUGPA) Specialty Network. He also co-chairs the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology, and he also serves as an editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons.
