Bayer Seeks to Broaden Nubeqa’s Use in Prostate Cancer with Chemotherapy-Free Treatment Option

Bayer's Nubeqa Expansion Plans:
Bayer is pursuing a label expansion for Nubeqa (darolutamide) to treat metastatic hormone-sensitive prostate cancer (mHSPC) without additional chemotherapy, following positive Phase III trial results.

ARANOTE Trial Success:
The ARANOTE trial demonstrated a statistically significant and clinically meaningful increase in radiological progression-free survival (rPFS) when Nubeqa was combined with androgen deprivation therapy (ADT) compared to placebo and ADT.

Current Approval:
Nubeqa is currently approved by the US FDA for treating mHSPC in combination with docetaxel chemotherapy and for non-metastatic castration-resistant prostate cancer (nmCRPC).

Future Treatment Flexibility:
The potential approval would allow physicians to tailor Nubeqa treatment plans with or without docetaxel based on individual patient needs.

Ongoing Clinical Development:
Bayer is evaluating Nubeqa in various prostate cancer stages, including the Phase III ARASTEP trial for non-metastatic HSPC and the Phase III DASL-HiCaP trial for localized prostate cancer with a high risk of recurrence.