Bayer has applied for European Union (EU) approval of Nubeqa (darolutamide) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). This application follows the presentation of data from the Phase III ARANOTE trial, which demonstrated a significant benefit in radiographic progression-free survival (rPFS) when Nubeqa was used in combination with hormone therapy.
The ARANOTE trial evaluated Nubeqa in patients with mHSPC. The results indicated a statistically significant improvement in rPFS compared to placebo when both were combined with hormone therapy. Detailed findings from the trial were previously presented and have formed the basis of this regulatory submission.
Nubeqa is currently approved in numerous countries for mHSPC when used alongside hormone therapy and chemotherapy. It is also approved for the treatment of patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastases (high-risk mCRPC). The expansion of Nubeqa's approved indications could provide a valuable new treatment option for a broader range of patients with prostate cancer.
Sales of Nubeqa have shown strong growth, and the drug is projected to exceed one billion in sales in 2024. This growth reflects the increasing adoption of Nubeqa in the treatment landscape for prostate cancer.
