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【FDA Approval Alert】Bayer’s darolutamide (Nubeqa) Approved for Metastatic Castration-Sensitive Prostate Cancer (June 3, 2025)
On June 3, 2025, the U.S. FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). While previously approved in combination with docetaxel, this new approval expands its indication as monotherapy. Approval was based on the ARANOTE trial (NCT02799602).
Disease Overview: Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
mCSPC is an advanced form of prostate cancer that still responds to androgen deprivation therapy. Treatment typically includes hormonal therapy combined with novel hormone agents or chemotherapy.
Treatment Summary
- Drug Name: darolutamide (Nubeqa)
- Company: Bayer Healthcare Pharmaceuticals Inc.
- Approval Date: June 3, 2025
- Indication: Metastatic castration-sensitive prostate cancer (mCSPC)
- Mechanism of Action: Androgen receptor inhibition
- Pivotal Trial: ARANOTE (NCT02799602)
- Key Efficacy:
- rPFS: HR 0.54 (95% CI: 0.41–0.71, p<0.0001)
- OS: No significant difference (HR 0.78; 95% CI: 0.58–1.05)
Patient-Friendly Summary
Nubeqa helps suppress disease progression in advanced prostate cancer when combined with hormone therapy, offering a non-chemotherapy treatment option.
M&A Information
- Subsidiary: Not applicable (Bayer in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (ETR: BAYN)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
