FDA OKs additional indication of darolutamide-docetaxel combo for prostate cancer

 Orion’s collaboration partner Bayer today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

The approval is based on positive results of the Phase III ARASENS trial that demonstrated darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. These results were recently published in The New England Journal of Medicine.¹ Darolutamide is approved in more than 70 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa®, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer.

https://www.biospace.com/article/releases/u-s-fda-approves-additional-indication-of-darolutamide-in-combination-with-docetaxel-for-the-treatment-of-metastatic-hormone-sensitive-prostate-cancer-mhspc-/