Bayer Submits Application for NUBEQA to USFDA and EMA
Bayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration USFDA as well as the submission of a Variation Type II application to the European Medicines Agency for the oral androgen receptor inhibitor NUBEQA;
Whippany: Bayer today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration (FDA) as well as the submission of a Variation Type II application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor NUBEQA (darolutamide). Bayer is seeking approval for the use of NUBEQA in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
The submissions are supported by positive results from the investigational Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for NUBEQA plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.1
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