EU approval for new non-metastatic castration-resistant prostate cancer drug

Following a positive European Medicines Agency advisory recommendation in January this year, the European Commission has now granted formal marketing authorization in the European Union for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi).

The compound, which is developed jointly by Germany’s Bayer (BAYN: DE) and originator Finland-based Orion Corp (Nasdaq: OMX), is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Bayer is responsible for global commercialization, with a co-promotion of Bayer and Orion in certain European markets, eg, France, Germany, Italy, Spain, the UK, Scandinavia and Finland.

The EU approval is based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. Results demonstrated a highly-significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median of 40.4 months, versus 18.4 months for placebo plus ADT (p<0.001), and a favorable safety profile.