Second indication for Bayer and Orion's Nubeqa in Europe

1 March 2023

The European Commission has granted marketing authorization for Nubeqa (darolutamide) alongside androgen deprivation therapy in combination with docetaxel, to treat metastatic hormone-sensitive prostate cancer (mHSPC).

Nubeqa, an oral androgen receptor inhibitor from Bayer (BAYN: DE) and Orion Corp (Nasdaq: OMX), is already approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

Christine Roth, a member of the executive committee of Bayer’s Pharmaceuticals Division and head of the Oncology Strategic Business Unit, said: “Today’s approval of Nubeqa represents a significant milestone in addressing unmet medical needs for people living with metastatic hormone-sensitive prostate cancer in Europe.

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