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
This report summarizes the assessment of AstraZeneca's variation application for Faslodex (fulvestrant). The application aimed to expand the indication to include patients who had progressed on aromatase inhibitor therapy and to update the Summary of Product Characteristics (SmPC) using data from the CONFIRM, NEWEST, and FINDER studies. While the Committee for Medicinal Products for Human Use (CHMP) did not approve the extended indication, it did agree to incorporate the new study data into the SmPC.
Key findings — cited to the page
| Median TTP in patients with prior Aromatase inhibitor (Fulvestrant 500 mg) | 5.4 | CONFIRM (D66997C00002) · p.20 |
| Median TTP in patients with prior Aromatase inhibitor (Fulvestrant 250 mg) | 4.1 | CONFIRM (D66997C00002) · p.20 |
| TTP HR in patients with prior Aromatase inhibitor (Fulvestrant 500 mg vs 250 mg) | 0.85 | CONFIRM (D66997C00002) · p.20 |
| TTP p-value in patients with prior Aromatase inhibitor (Fulvestrant 500 mg vs 250 mg) | 0.195 | CONFIRM (D66997C00002) · p.20 |
| Median TTP in patients with prior Anti-estrogen (Fulvestrant 500 mg) | 8.6 | CONFIRM (D66997C00002) · p.20 |
| Median TTP (Fulvestrant 250 mg) | 5.5 | CONFIRM (D66997C00002) · p.19 |
| Marketing Authorisation Grant Date | 10 March 2004 | Faslodex (fulvestrant) · p.2 |
| Fulvestrant recommended dose | 500 mg | Faslodex (fulvestrant) · p.2 |
| CONFIRM study design | Phase III | CONFIRM (D66997C00002) · p.3 |
| CONFIRM study patients randomized (Fulvestrant 500 mg arm) | 362 | CONFIRM (D66997C00002) · p.3 |
| CONFIRM study patients randomized (Fulvestrant 250 mg arm) | 374 | CONFIRM (D66997C00002) · p.3 |
| TTP p-value in patients ≥ 65 years (Fulvestrant 500 mg vs 250 mg) | 0.207 | CONFIRM (D66997C00002) · p.20 |
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 →