FDA Approves Nubeqa for Prostate Cancer

The Food and Drug Administrated (FDA) approved Nubeqa (darolutamide) under a priority review to treat men with non-metastatic castration-resistant prostate cancer, according to Bayer, the drug’s manufacturer.

The agency based its approval on data from the randomized, double-blind, placebo-controlled, multi-center phase 3 ARAMIS trial — designed to evaluate Nubeqa, an androgen receptor inhibitor, plus androgen deprivation therapy in 1,509 patients with non-metastatic castration-resistant prostate cancer.

The trial showed a significant improvement in metastasis-free survival — the measure of time from diagnosis or treatment to appearance of a distant metastasis (cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes). The median metastasis-free survival was 40.4 months compared with 18.4 months for placebo plus androgen deprivation therapy.

Nine percent of patients in both arms discontinued treatment due to side effects, with the most frequent being fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%) In the Nubeqa and placebo arms, respectively.

The FDA's priority review designation is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions.

Check back later for more information on what this means for these patients.