Orion's blockbuster prostate drug gains key EU panel backing

A European Medicines Agency panel recommended expanding the use of a prostate cancer drug from Orion and its partner Bayer, moving the blockbuster treatment a step closer to a third approval in the region.

The agency's Committee for Medicinal Products for Human Use issued a positive opinion for darolutamide, sold as Nubeqa, to be used with androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer, the companies said.

The recommendation is based on a late-stage study that showed the drug combination reduced the risk of radiological progression or death by 46% compared to a placebo, according to the company.

A final marketing authorization decision from the European Commission is expected in the coming months.

The move follows a similar approval earlier this month in the U.S., where the Food and Drug Administration cleared darolutamide for the same patient group.

Nubeqa is already approved in the European Union for treating the same condition in combination with chemotherapy, and for another form of prostate cancer known as non-metastatic castration-resistant prostate cancer.

The drug, which Orion developed jointly with Bayer, achieved blockbuster status in September 2024, with reported sales of 1.52 billion euros for the full year.