Bayer, Orion Seek Darolutamide’s Approval in Europe for Non-metastatic CRPC

Bayer, Orion Seek Darolutamide’s Approval in Europe for Non-metastatic CRPC
Bayer and Orion have successfully submitted an application to the European Medicines Agency seeking the approval of darolutamide for men with non-metastatic castration-resistant prostate cancer (nmCRPC). The application follows promising results from the ARAMIS Phase 3 trial (NCT02200614), where a combination of darolutamide and androgen deprivation therapy (ADT) delayed cancer spread by 22 months, compared to ADT only. The findings were presented during the 2019 Genitourinary Cancers Symposium in San Francisco and have been published in The New England Journal of Medicine. Currently, Erleada (apalutamide) and Xtandi (enzalutamide) are the only two androgen receptor inhibitors approved to delay cancer's spread in CRPC patients. However, both therapies are associated with toxicities that may affect patients’ quality of life. Darolutamide is an oral androgen receptor inhibitor, meaning that it prevents the binding of testosterone to the andr
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