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Overview
nmCRPC
mHSPC

NUBEQA® (darolutamide) Guidelines in mHSPC

NUBEQA is recommended by NICE and accepted for use by the SMC and fully funded throughout the UK

 

Approved by NICE

Recommended as a treatment option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease, and in combination with androgen deprivation therapy (ADT) and docetaxel for adult men with hormone-sensitive metastatic prostate cancer.

 

SMC accepted

For the treatment of adults with non-metastatic castration resistant prostate cancer who are at high risk of developing metastatic disease, and for adults with hormone-sensitive prostate cancer in combination with docetaxel and ADT.

 

NUBEQA is recommended by EAU guidelines for mHSPC

6.4.8. Guidelines for the first-line treatment of hormone-sensitive metastatic disease*[5]

Recommendation

Strength rating

Offer docetaxel only in combination with ADT plus abiraterone or darolutamide to patients with M1 disease and who are fit for docetaxel.

Strong

* metastatic disease defined by bone scintigraphy and CT scan/MRI.

To learn more about treating patients with NUBEQA in mHSPC click here

PP-NUB-GB-2001 | January 2025

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Resources
    • 1
      NICE. Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer. ta104761. 2020. Available at https://www.nice.org.uk/guidance/gid-ta10476/documents/final-appraisal-determination-document (last accessed January 2025).
    • 2
      NICE. Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer. Ta903. Available at https://www.nice.org.uk/guidance/ta903/resources/darolutamide-with-androgen-deprivation-therapy-and-docetaxel-for-treating-hormonesensitive-metastatic-prostate-cancer-pdf-82615424991685 (last accessed January 2025).
    • 3
      SMC. Medicines advice darolutamide. SMC2297. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-full-smc2297 (last accessed January 2025).
    • 4
      SMC. Medicines advice darolutamide. SMC2604. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-ft-resub-smc2604 (last accessed January 2025).
    • 5
      European Association of Urology. Prostate cancer guidelines (2019; amended 2020). Available at: https://uroweb.org/guideline/prostate-cancer/ (last accessed January 2025).