Ferring A S — Firmagon EMA EPAR variation assessment report (EMEA/H/C/000986, 2009)
Ferring A S · 2009 · EMA EPAR variation assessment report
Report summary
This report summarizes a Type II variation application for Ferring Pharmaceuticals A/S's Firmagon (degarelix), submitted in November 2020. The application seeks to expand Firmagon's indications to include high-risk localized and locally advanced hormone-dependent prostate cancer, for use with radiotherapy and as neo-adjuvant treatment. The submission relies on literature review and existing guidelines, with no new non-clinical or pharmacokinetic data, and the dosage remains unchanged. The report also details an assessment comparing degarelix to goserelin in prostate cancer treatment, analyzing trial designs, statistical methods, and efficacy outcomes such as testosterone suppression, PSA reduction, and prostate volume changes. Degarelix demonstrated non-inferiority to goserelin across several key endpoints.
Key findings — cited to the page
| MA granted in Europe | February 2009 | Firmagon · Europe · p.8 |
| Testosterone suppression level | 0.5 ng/ml | Firmagon · p.8 |
| Fpen for degarelix in Sweden | 0.25 % | degarelix · Sweden · p.9 |
| Study CS12 median age | 72 years | CS12 · p.10 |
| Study CS21 median age | 72 years | CS21 · p.10 |
| Study CS30 median age | 71 years | CS30 · p.10 |
| randomization ratio | 1:1 | · p.14 |
| trial type | open-label | · p.14 |
| 1-year cumulative probability of testosterone levels below castrate level (≤0.5 ng/mL) | >-10% | · p.14 |
| patients analyzed for efficacy (degarelix) | 143 patients | · p.16 |
| patients analyzed for efficacy (goserelin ± bicalutamide) | 142 patients | · p.16 |
| mean change TVP (control, FAS) | 35.3 % | Study CS30 · p.28 |
Source: Ferring A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →