Degarelix
Degarelix (Firmagon, Ferring Pharmaceuticals A/S) has 3 EU-approved indications in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Prostate cancer3 | |||
None | Monotherapy | Neoadj. | High-risk localised or locally advanced; hormone-dependent disease |
None | + radiotherapy | Any line | High-risk localised or locally advanced; hormone-dependent disease |
None | Monotherapy | Any line advanced | Hormone-dependent disease |
Full text of section 4.1 (therapeutic indications)
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.
Label history
18 changes to the Firmagon label since 2009, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes