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.
The European Commission approved the drug, also known as darolutamide, for patients with metastatic hormone-sensitive prostate cancer, a form of the disease where the cancer has spread.
The approval was based on a late-stage trial that showed the drug, when combined with androgen deprivation therapy, reduced the risk of radiological disease progression or death by 46% compared to a placebo, according to the company.
This decision follows a similar U.S. approval and comes as soaring sales of Nubeqa drive strong financial results for the Finnish drugmaker.
Orion recently reported a 59% surge in second-quarter operating profit to 104.6 million euros and raised its full-year financial forecast, citing the drug's performance.
"Operating profit increased faster than net sales mainly due to the growth of Nubeqa® royalties," President and CEO Liisa Hurme said in the company's latest earnings report.
Nubeqa is already approved in the EU for other prostate cancer indications and is developed jointly by Orion and Germany's Bayer.
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