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Nubeqa™ (darolutamide) approved for additional prostate cancer indication in China - Vimarsana News

Nubeqa™ (darolutamide) approved for additional prostate cancer indication in China

Nubeqa™ now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer / Additional indication based on data from the pivotal Phase III ARASENS trial 

Source: bayer.com
New NUBEQA® (darolutamide) Subgroup Analyses from the Phase III ARASENS Trial in Metastatic Hormone- - Vimarsana News

New NUBEQA® (darolutamide) Subgroup Analyses from the Phase III ARASENS Trial in Metastatic Hormone-

New post hoc subgroup analyses from Phase III ARASENS trial in mHSPC show that NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel increased overall survival (OS) in specific subgroups with various types of metastatic disease burden and risk1Incidence of adverse events was simi...

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U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for - Vimarsana News

U.S. FDA Approves Additional Indication of NUBEQA® (darolutamide) in Combination with Docetaxel for

NUBEQA now has indications in both metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC)1Today’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...