Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New England Journal of Medicine, showing that the use of darolutamide plus androgen deprivation therapy and docetaxel led to a statistically significant improvement in overall survival compared to androgen deprivation therapy plus docetaxel as well as consistent benefits in key secondary endpoints in patients with mHSPC, with similar overall rates of adverse events between study arms.
Bayer today announced the submission of a supplemental new drug application to the U.S. FDA as well as the submission of a Variation Type II application to the EMA for the oral androgen receptor inhibitor darolutamide.
