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NUBEQA® (darolutamide) Guidelines in nmCRPC
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 nmCRPC
6.5.16. Guidelines for non-metastatic castrate-resistant disease | |
|---|---|
Recommendation | Strength rating |
Offer apalutamide, darolutamide or enzalutamide to patients with M0 CRPC and a high risk of developing metastasis (PSA-DT < 10 months) to prolong time to metastases. | Strong |
Abbreviations: CRPC, castration-resistant prostate cancer; M0, non-metastatic; PSA-DT, prostate-specific antigen-doubling time.
PP-NUB-GB-1998 | January 2025
- Referencesexpand_more
- 1NICE. 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).
- 2NICE. 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).
- 3SMC. Medicines advice darolutamide. SMC2297. Available at: https://www.scottishmedicines.org.uk/medicines-advice/darolutamide-nubeqa-full-smc2297 (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).
- 5European Association of Urology. Prostate cancer guidelines (2019; amended 2020). Available at: https://uroweb.org/guideline/prostate-cancer/ (last accessed January 2025).