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.
More from this issuer
Related coverage
Orion has secured an exclusive license for an experimental cancer antibody from Abzena, the latest in a series of deals to strengthen its oncology pipeline following a recent clinical trial failure.
Finnish drugmaker Orion Corp. said Tuesday its experimental insomnia drug failed a mid-stage clinical trial, days after investment giant BlackRock Inc. cut its stake in the company.
Orion and its partner Bayer have secured European Union approval for an expanded use of their blockbuster prostate cancer drug, Nubeqa, the latest in a series of regulatory wins for the treatment.
Orion Corp. reported a 59% surge in second-quarter operating profit, driven by strong sales and royalty income from its blockbuster prostate cancer drug, Nubeqa.