FDA OKs Bayer’s Nubeqa for Prostate Cancer

FDA has approved a Bayer NDA for Nubeqa (darolutamide), an androgen receptor inhibitor for treating patients with non-metastatic castration-resistant prostate cancer. Approval is based on data from the Phase 3 ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival, with a median of 40.4 months versus 18.4 months for placebo plus ADT, according to the company.

In the ARAMIS trial, both arms showed a 9% discontinuation rate due to adverse reactions. The most frequent adverse reactions requiring discontinuation in patients who received Nubeqa included cardiac failure (0.4%), and death (0.4%). Adverse reactions occurring more frequently in the Nubeqa arm were fatigue (16% versus 11% in placebo arm), pain in extremity (6% versus 3%) and rash (3% versus 1%).