This site contains promotional content intended for UK Healthcare Professionals and other relevant decision makers | Not a HCP? Visit our Public Site.
Adverse Event reporting can be found at the bottom of the page | Prescribing Information for the relevant medicine can be found adjacent to the below content and/or in the footer below.

About NUBEQA® (darolutamide) in mHSPC
For adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
For your patients with mHSPC, who often face high disease burden and require intensified treatment, NUBEQA is the only NICE-recommended and SMC-accepted therapy in combination with ADT and docetaxel with proven efficacy and tolerability and a distinct molecular structure.
Adding NUBEQA to ADT and docetaxel not only extends overall survival, but also maintains QoL with <1% increase in AEs incidence vs ADT and docetaxel, despite an intensified therapy approach.
- Do current therapies help you achieve the treatment goals of men with mHSPC?expand_moremHSPC Checklist for NUBEQAYou can download the NUBEQA checklist for mHSPC using the button below.
- In mHSPC, NUBEQA + ADT in combination with docetaxel was investigated in ARASENS, a Phase 3, double-blind, placebo-controlled, multi-centre studyexpand_more
NUBEQA + ADT in combination with docetaxel was investigated in ARASENS, a double-blind, placebo-controlled, multi-centre study. This study analysed 1,305 men with mHSPC (de novo + recurrent) who were randomised 1:1 to two arms: NUBEQA + ADT + docetaxel (n=651) and placebo + ADT + docetaxel (n=654). The primary endpoint of the study was overall survival (OS).
* The secondary endpoints were tested with a hierarchical gatekeeping procedure. If the primary endpoint or a secondary endpoint did not reach significance, the hierarchical procedure was stopped, and subsequent analyses were considered to be exploratory.
- Clinically proven and recommended by NICE: Extend survival by >30% when adding NUBEQA (darolutamide) to ADT and docetaxelexpand_more
NUBEQA's efficacy is backed by robust clinical data and supported by international guidelines. NUBEQA is the only NICE-recommended and SMC-accepted therapy in combination with ADT and docetaxel.
For your patients with mHSPC who need treatment intensification, NUBEQA added to ADT and docetaxel can extend their overall survival by >30% vs. ADT and docetaxel alone.
NUBEQA + ADT + docetaxel: 32.5% reduced risk of death vs. placebo + ADT + docetaxel (primary endpoint)†Adapted from Smith M et al. 2022.
- At 4 years, the overall survival rate with NUBEQA + ADT + docetaxel was 62.7% (95% CI: 58.7–66.7%) vs. 50.4% (95% CI: 46.3–54.6%) with placebo + ADT + docetaxel.
† ARASENS trial. Men with mHSPC. NUBEQA + ADT + docetaxel (n=651) vs. placebo + ADT + docetaxel (n=654). Primary endpoint was OS. 32.5% reduction in risk of death vs. placebo + ADT + docetaxel. Number of patients with events 229/651 (35.2%) vs. 304/654 (46.5%) with placebo + ADT + docetaxel. Median OS: NE months vs. 48.9 months with placebo + ADT + docetaxel (HR: 0.68; 95% CI: 0.57–0.80; p<0.001). Docetaxel 75 mg/m2 q3w x 6 cycles.
- Maintain your patient’s QoL with NUBEQA (darolutamide): <1% increase in AE incidence when added to ADT and docetaxelexpand_more
When adding NUBEQA to ADT and docetaxel, almost 9 out of 10 patients completed all six docetaxel cycles (87.6% vs 85.5%)
After completing all docetaxel cycles, patients with mHSPC remained on treatment with NUBEQA and ADT longer than those on ADT + placebo (median 41.0 months vs 16.7 months).
NUBEQA’s proven tolerability allowed patients to stay on treatment, without further impacting their QoL and daily routines
Adapted from NUBEQASummary of Product Characteristics and data on file.
- Discontinuation rates due to AEs were 13.7% (NUBEQA with docetaxel and ADT) vs. 10.6% (Placebo with docetaxel and ADT).
† Adverse reactions incidences may not be attributable to darolutamide alone but may contain contributions from other medicinal products used in combination.
‡ Includes rash, rash maculopapular, drug eruption, rash pruritic, rash erythematous, rash follicular, rash pustular, rash vesicular, erythema, dermatitis. The incidence was highest during the first 6 months of treatment.
# Includes hypertension, blood pressure increased, hypertensive emergency.
- Dosingexpand_more
mHSPC patients should start NUBEQA in combination with docetaxel. The first of 6 cycles of docetaxel should be administered within 6 weeks after the start of NUBEQA treatment. The recommendation in the product information of docetaxel should be followed. Treatment with NUBEQA should be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued.
Two 300 mg tablets, twice daily with food
For more information about dosing modifications, missed doses, special warnings, precautions and interactions, please refer to the Summary of Product Characteristics.
- NUBEQA is fully funded throughout the UKexpand_more
NUBEQA is the only ARi in combination with docetaxel to be accepted for use by the SMC and recommended by NICE in mHSPC.
Approved by NICE
Recommended as a treatment with androgen deprivation therapy (ADT) and docetaxel for adult men with hormone-sensitive metastatic prostate cancer.
SMC accepted
For treatment of adults with hormone-sensitive prostate cancer in combination with docetaxel and ADT.
Combining three different modes of action offers you a different approach to potentially extending survival in mHSPC vs placebo + ADT + docetaxel.
PP-NUB-GB-1993 | February 2025
- Referencesexpand_more
- 1NUBEQA (darolutamide) Summary of Product Characteristics.
- 2Smith MR et al. N Engl J Med. 2022;386(12):1132–1142.
- 3NICE. Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10860 (last accessed January 2025).
- 4SMC. Medicines advice darolutamide. SMC2604. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-ft-resub-smc2604 (last accessed January 2025).
- 5Heidegger I, et al. Urol Oncol. 2020;38(4):129–136.
- 6SMC. Medicines advice apalutamide. SMC2472. Available at: https://www.scottishmedicines.org.uk/medicines-advice/apalutamide-erleada-full-smc2472 (last accessed January 2025).
- 7SMC. Medicines advice enzalutamide. SMC2400. Available at: https://www.scottishmedicines.org.uk/medicines-advice/enzalutamide-xtandi-full-smc2400 (last accessed January 2025).
- 8NICE. Enzalatamide for treating hormone-sensitive metastatic prostate cancer. Available at: https://www.nice.org.uk/guidance/ta712 (last accessed January 2025).
- 9NICE. Apalutamide for treating hormone-sensitive metastatic prostate cancer. Available at: https://www.nice.org.uk/guidance/ta741 (last accessed January 2025).
- 10Bayer. Data on file. REF-M_DAR-GB-0641. May 2023.
- 11Bayer. Data on file. REF-M_DAR-GB-0683.