U.S. FDA Approves New Indication for Orion-Bayer Prostate Cancer Drug

Orion's collaboration partner Bayer announced U.S. FDA approval for darolutamide, an androgen receptor inhibitor (ARi), for metastatic hormone-sensitive prostate cancer (mHSPC).

This marks the drug's third indication, allowing its use with androgen deprivation therapy (ADT), with or without chemotherapy.

The approval stems from the pivotal Phase III ARANOTE trial, where darolutamide plus ADT significantly cut the risk of radiological progression or death by 46%.

According to the company, this reinforces darolutamide's established safety profile.

The drug, marketed as Nubeqa, achieved annual sales of EUR 1.52 billion in 2024.