The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for darolutamide (Bayer and Orion), an investigational treatment for non-metastatic castration-resistant prostate cancer (nmCRPC).
Darolutamide, a non-steroidal androgen receptor (AR) antagonist with a distinct chemical structure, works by inhibiting the growth of prostate cancer cells. The NDA submission includes data from the phase 3 ARAMIS trial, which included 1509 patients with mmCRPC; patients were randomized 2:1 to receive darolutamide 600mg twice daily or placebo along with androgen deprivation therapy.
Results of the study showed that the median metastasis-free survival (primary endpoint defined as time between randomization and evidence of metastasis or death) was 40.4 months with darolutamide vs 18.4 months for placebo. The hazard ratio for metastasis or death in the darolutamide group was 0.41 (95% CI, 0.34 to 0.50; P <.001). With regard to safety, the incidence of adverse events was similar between the 2 treatment groups.
“With the NDA acceptance and Priority Review designation, we are an important step closer to bringing darolutamide to patients as quickly as possible,” said Scott Z. Fields, MD, senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division.
Darolutamide is also being evaluated in a phase 3 study (ARASENS) involving patients with metastatic hormone sensitive prostate cancer.
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