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 androgen receptor, blocking the signals that fuel prostate cancer growth. Its structure, however, is distinct from other inhibitors of the androgen receptor, potentially being less toxic to patients. ARAMIS was designed to determine whether darolutamide could safely delay metastasis in CRPC patients at high risk. It included 1,509 patients with non-metastatic CRPC whose prostate-specific antigen (PSA) levels were rapidly rising while receiving androgen deprivation therapy. During the trial, all participants continued to receive hormone therapy and were randomly either assigned oral darolutamide (955 patients) or a placebo (554 patients) twice daily. Investigators found that patients given a combination of darolutamide and ADT lived a median 40.4 months without their cancer spreading, compared to 1
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