Advice

in the absence of a submission from the holder of the marketing authorisation:

darolutamide (Nubeqa®) is not recommended for use within NHSScotland.

Indication under review: treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result, we cannot recommend its use within NHSScotland.

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Medicine details

Medicine name:
darolutamide (Nubeqa)
SMC ID:
SMC2940
Indication:

Treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

Pharmaceutical company
Bayer Plc
BNF chapter
Malignant disease and immunosuppression
Submission type
Non submission
Status
Not recommended
Date advice published
08 June 2026