Bayer: files application for darolutamide in EU

(CercleFinance.com) - Bayer has announced the filing of an application with the European Medicines Agency (EMA) for darolutamide, an orally administered androgen receptor inhibitor (ARi).


Bayer is seeking authorisation to use darolutamide, in combination with androgen deprivation therapy (ADT), in patients with hormone-sensitive metastatic prostate cancer (mHSPC).

The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets worldwide.

The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in over 85 countries worldwide.

Every man with hormone-sensitive metastatic prostate cancer has unique needs. It is essential to provide physicians with options to tailor treatment plans to the individual, whether with or without chemotherapy, Bayer said.


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