U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) August 9, 2022 FOR IMMEDIATE RELEASEMEDIA CONTACT:Scott Meeks scott@zerocancer.orgWashington, 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).1 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 profile1Read the full press release here.ReferencesNUBEQA® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, August 2022. Press Release
FOR IMMEDIATE RELEASEMEDIA CONTACT:Scott Meeks scott@zerocancer.orgWashington, 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).1 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 profile1Read the full press release here.ReferencesNUBEQA® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, August 2022.
