Bayer seeks EU nod to third indication of Darolutamide
Berlin: Bayer said on Monday that it has applied to the EU's drugs regulator for the use of Nubeqa, also known as darolutamide, in combination with androgen deprivation therapy.
It said the submission to the European Medicines Agency (EMA) was based on positive results from a phase III trial that showed darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46 per cent compared with placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer.
The compound is already approved in combination with ADT and docetaxel in over 80 markets around the world, and in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease in more than 85 countries around the world.
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