Bayer Submits Applications in the U.S. and EU for Additional Indication of NUBEQA® (darolutamide)

  • Submissions in the U.S. and European Union (EU) for an additional indication in patients with metastatic hormone-sensitive prostate cancer (mHSPC)
  • Submissions are based on data from the investigational Phase III ARASENS trial recently published in The New England Journal of Medicine,showing that the use of NUBEQA plus androgen deprivation therapy (ADT) and docetaxel led to a statistically significant improvement in overall survival (OS) compared to ADT plus docetaxel as well as a statistically significant benefit across multiple secondary endpoints in patients with mHSPC, with similar overall rates of adverse events (AEs) between study arms1
  • NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC); additional submissions in mHSPC are planned globally
  • Broad development program underway with additional ongoing or planned large clinical studies for NUBEQA across various stages of prostate cancer
Reno, Nevada (UroToday.com) -- Bayer announced the submission of a supplemental new drug application (sNDA) 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 (ARi) 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


“For men with mHSPC, there remains a high need for new treatment options that can extend overall survival and delay the progression to CRPC,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of the Oncology SBU at Bayer. “Prostate cancer is a key area of focus at Bayer and the U.S. and EU submissions for NUBEQA in mHSPC represent a significant milestone in our commitment to developing treatments that support men with prostate cancer throughout the different stages of the disease.”
Additional submissions in mHSPC are planned globally. NUBEQA is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

References: 

  1. Smith M., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022.

Source: "Bayer Submits Applications In The U.S. And EU For Additional Indication Of NUBEQA® (Darolutamide)". 2022. Bayer2019tf.Q4web.Com.
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