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U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

FOR IMMEDIATE RELEASE

MEDIA CONTACT:

Scott Meeks
scott@zerocancer.org

Washington, D.C., Aug. 05, 2022 Bayer announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).Today’s approval under the FDA’s Real-Time Oncology Review (RTOR) pilot program was based on the pivotal Phase III ARASENS trial, which showed a significant overall survival (OS) benefit with NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel1 NUBEQA is the only androgen receptor inhibitor (ARi) approved in combination with docetaxel for mHSPC, demonstrating a 32% reduction in the risk of death compared to docetaxel alone and with a proven tolerability profile1

Read the full press release here.

References

  1. NUBEQA® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, August 2022.

About ZERO — The End of Prostate Cancer
ZERO — The End of Prostate Cancer is the leading national nonprofit with the mission to end prostate cancer and help all who are impacted. ZERO advances research, provides support, and creates solutions to achieve health equity to meet the most critical needs of our community. From early detection to survivorship, ZERO is the premier resource for prostate cancer patients and their families to access comprehensive support, make meaningful connections, and take action to save lives. Our dedicated national and chapter staff is joined with a growing team of passionate volunteer champions to increase advocacy, awareness, and community engagement to ZERO out prostate cancer. ZERO is recognized with four out of four stars by Charity Navigator and accredited by the Better Business Bureau. ZERO spends more on programs than any other prostate cancer charity, dedicating 85 cents of every dollar to support, education, and research.