AstraZeneca PLC — Faslodex EMA EPAR public assessment report (EMEA/H/C/000540, 2004)
AstraZeneca PLC · 2004 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA EPAR for Faslodex (fulvestrant), approved for postmenopausal women with ER-positive, locally advanced or metastatic breast cancer. Fulvestrant, an ER Downregulator administered as a 250 mg/5ml intramuscular injection, demonstrated preclinical efficacy in tamoxifen-resistant cells and an acceptable safety profile. Clinical studies, including pivotal Phase III trials (0020 and 0021) comparing fulvestrant to anastrozole, showed non-inferior efficacy for fulvestrant in terms of time to progression, duration of response, and objective response rate, though differences were not statistically significant. Pharmacokinetic and pharmacodynamic data supported its use. While effective, post-marketing surveillance is recommended for potential safety concerns like bone density, endometrial effects, and thromboembolic events. Ongoing studies aim to optimize dosing and further assess safety.
Key findings — cited to the page
| number of patients randomized to fulvestrant 125 mg | 163 | Studies 0020 and 0021 · p.15 |
| Scientific Advice sought from CPMP | 1997 | · p.9 |
| number of patients randomized to anastrozole 1 mg | 423 | Studies 0020 and 0021 · p.15 |
| proposed dose | 250 mg | Faslodex · p.1 |
| number of Phase II efficacy studies | 2 | Studies 0004 and O-15-22 · p.9 |
| number of Clinical pharmacology studies | 18 | · p.9 |
| number of patients randomized in Studies 0020 and 0021 | 1014 | Studies 0020 and 0021 · North America, Europe, Australia, South Africa · p.15 |
| number of patients randomized to fulvestrant 250 mg | 428 | Studies 0020 and 0021 · p.15 |
| active substance | fulvestrant (ICI 182,780, ZD9238) | Faslodex · p.1 |
| therapeutic indication | treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antioestrogen therapy or disease progression on therapy with an antioestrogen | Faslodex · p.1 |
| number of Phase III pivotal efficacy studies | 2 | Studies 0020 and 0021 · p.9 |
| median age for patients randomized to anastrozole in Study 0021 | 61 years | Study 0021 · p.16 |
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 →