Abiraterone
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Prostate cancer3 | |||
None | + prednisone or prednisolone | 1L metastatic | Castration-resistant only; Failure of androgen deprivation therapy; Asymptomatic or mildly symptomatic; chemotherapy is not yet clinically indicated |
None | + prednisone or prednisolone, and androgen deprivation therapy (ADT) | 1L metastatic | Hormone-sensitive only; Newly diagnosed; high risk |
None | + prednisone or prednisolone | 2L metastatic | Castration-resistant only; Progressed on or after a docetaxel-based chemotherapy regimen |
Full text of section 4.1 (therapeutic indications)
Abiraterone Krka is indicated with prednisone or prednisolone for: - the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) - the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) - the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
ZYTIGA is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Label history
30 changes to the Zytiga label since 2012, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Product
Changes