AstraZeneca PLC — Faslodex EMA EPAR variation assessment report (EMEA/H/C/000540, 2004)
AstraZeneca PLC · 2004 · EMA EPAR variation assessment report · company profile →
Report summary
AstraZeneca UK Ltd submitted a Type II variation for Faslodex (fulvestrant) to expand its indication to include postmenopausal women with hormone receptor-positive, locally advanced or metastatic breast cancer who have not received prior endocrine therapy. This application is supported by data from the FIRST (Phase 2) and FALCON (Phase 3) studies, comparing fulvestrant 500 mg with anastrozole 1 mg. The FALCON study demonstrated borderline significant superiority in progression-free survival (PFS) for fulvestrant. The FIRST study met its non-inferiority objective for Clinical Benefit Response and showed improved PFS and overall survival. Fulvestrant's safety profile is well-established, with no new adverse drug reactions identified.
Key findings — cited to the page
| AE Grade ≥3 (control arm) | 18 % | · p.57 |
| AE Grade ≥3 (fulvestrant arm) | 22 % | · p.57 |
| AE Grade ≥3, Related (fulvestrant arm) | 4 % | · p.57 |
| AE Grade ≥3, Related (control arm) | 2 % | · p.57 |
| Scientific Advice date | 22 November 2012 | Faslodex · p.6 |
| PFS Hazard Ratio (HR) | 0.69 | FALCON (Study D699BC00001) · p.14 |
| OS HR | 0.70 | FIRST · p.57 |
| Median PFS (anastrozole arm) | 13 months | FALCON (Study D699BC00001) · p.15 |
| Application submission date | 2 November 2016 | Faslodex · p.6 |
| Median PFS (fulvestrant arm) | 18.8 months | FALCON (Study D699BC00001) · p.15 |
| Smallest statistically significant PFS HR | 0.80 | FALCON (Study D699BC00001) · p.15 |
| Power | 90 % | FALCON (Study D699BC00001) · p.14 |
Source: AstraZeneca PLC ↗ · 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 →