The Food and Drug Administration has approved Nubeqa (darolutamide; Bayer), an androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration resistant prostate cancer (nmCRPC).

The approval was based on the ARAMIS study, a multicenter, randomized, double blind, placebo controlled phase 3 study that evaluated the safety and efficacy of Nubeqa in patients with nmCRPC who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analogue or had a bilateral orchiectomy (N=1509). The primary efficacy end point was metastasis free survival (MFS), defined as the time from randomization to the time of first evidence of blinded independent central review-confirmed distant metastasis or death due to any cause within 33 weeks after the last evaluable scan, whichever occurred first; overall survival (OS) and time to pain progression were included as additional efficacy end points.

Results demonstrated that patients treated with Nubeqa plus androgen deprivation therapy (ADT) had a statistically significant improvement in MFS with a median MFS of 40.4 months compared with 18.4 months for placebo plus ADT (hazard ratio [HR] 0.41, 95% CI (0.34, 0.50); P <.0001); MFS findings were also consistent across patient subgroups for prostate-specific antigen doubling time or prior use of bone-targeting agents. 

Moreover, a delay in time to pain progression (defined as at least a 2-point worsening from baseline of the pain score on Brief Pain Inventory-Short Form or initiation of opioids) was noted in patients treated with Nubeqa compared with placebo; OS data were not mature at the time of final MFS analysis.

With regard to safety, the most common adverse reactions were fatigue, pain in extremity, and rash. 

“Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” said Matthew Smith, MD, PhD, Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. “This approval marks an important new option for the prostate cancer community.”

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The Company is currently investigating the use of Nubeqa in metastatic hormone sensitive prostate cancer (ARASENS) in an ongoing phase 3 study.

Nubeqa will be supplied as 300mg film-coated tablets in 120-count bottles; it is expected to be available by next week.

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