The U.S. FDA has approved Bayer’s oral androgen receptor inhibitor, Nubeqa, in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC).
The expanded approval is based on positive results from the pivotal phase 3 ARANOTE trial, which showed that Nubeqa plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mCSPC. The oral tablets are taken twice daily.
With the approval in this third indication, Nubeqa plus ADT is indicated in the U.S. for the treatment of adult patients with mCSPC, either with or without docetaxel. In addition, Nubeqa is approved for the treatment of adult patients with non-metastatic castration-resistant prostate cancer, who are at high risk of developing metastatic disease.
First approved in 2019, Nubeqa hit blockbuster status in September 2024, with annual sales reaching $1.65 billion for the full year.