Apalutamide

Apalutamide (Erleada, Janssen-Cilag International NV) has 2 EU-approved indications in 1 tumour type.
Approved indications of Apalutamide
Biomarker requirementRegimenSettingConditions
Prostate cancer2
None
+ androgen deprivation therapy (ADT)
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)

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

Label history

23 changes to the Erleada label since 2020, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes