Bayer’s Prostate Cancer Drug Nubeqa Wins FDA Approval Despite 24% Rate of Serious Adverse Events

Bayer’s prostate cancer treatment Nubeqa has received Food and Drug Administration (FDA) approval for metastatic castration-sensitive prostate cancer (mCSPC) based on the phase 3 ARANOTE trial. In the trial, Nubeqa improved radiographic progression-free survival (rPFS) compared with androgen deprivation therapy (ADT) alone, but the incidence of serious adverse events reached 24%. Fatal adverse events were reported in 4.7%, which is expected to be a factor in the future expansion of prescribing.