Darolutamide

Darolutamide (Nubeqa, Bayer AG) has 3 EU-approved indications in 1 tumour type.
Approved indications of Darolutamide
Biomarker requirementRegimenSettingConditions
Prostate cancer3
None
+ androgen deprivation therapy
Any line
metastatic
Hormone-sensitive only
None
+ docetaxel and androgen deprivation therapy
Any line
metastatic
Hormone-sensitive only
None
Monotherapy
Any line
locally adv.
Castration-resistant only; High risk of developing metastatic disease
Full text of section 4.1 (therapeutic indications)

NUBEQA is indicated for the treatment of adult men with - non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). - metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). - metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

Label history

9 changes to the Nubeqa label since 2021, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes