ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019)
AstraZeneca PLC · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
AstraZeneca's Faslodex (fulvestrant) injection received FDA approval for a supplemental New Drug Application (sNDA) on September 9, 2010, increasing the dosage from 250 mg to 500 mg for hormone receptor-positive metastatic breast cancer in postmenopausal women. The pivotal CONFIRM trial demonstrated the 500 mg dose significantly improved progression-free survival (PFS) by 1.1 months and showed a trend for improved overall survival (OS) by 2.3 months compared to the 250 mg dose, without a significant increase in adverse events. The approval also included revisions for hepatic impairment. This comprehensive review covered pharmacokinetics, efficacy, safety, and regulatory aspects, including medication error analysis and packaging changes.
Key findings — cited to the page
| incidence of liver function abnormalities (grade >= 3) | 2 % | · p.44 |
| Grade ≥ 3 AE (pooled, fulvestrant 500 mg) | 15 % | CONFIRM, NEWEST, FINDER 1, FINDER 2 Trials · p.89 |
| Grade 3-4 increases in hepatic enzymes (ALT, AST, ALP) (FASLODEX) | 1-2 % of patients | FASLODEX · p.16 |
| incidence of liver function abnormalities (grade 1 or 2) | 15 % | · p.44 |
| Grade ≥ 3 treatment-emergent AEs (fulvestrant 500 mg arm) | 14.7 % | CONFIRM trial · p.87 |
| Grade ≥ 3 treatment-emergent AEs (fulvestrant 250 mg arm) | 16.0 % | CONFIRM trial · p.87 |
| Grade ≥ 3 musculoskeletal disorders (fulvestrant 500 mg arm) | 2.8 % | CONFIRM trial · p.92 |
| Grade ≥ 3 gastrointestinal disorders (fulvestrant 250 mg arm) | 1.3 % | CONFIRM trial · p.92 |
| Grade ≥ 3 gastrointestinal disorders (fulvestrant 500 mg arm) | 3.6 % | CONFIRM trial · p.92 |
| Grade ≥ 3 musculoskeletal disorders (fulvestrant 250 mg arm) | 5.3 % | CONFIRM trial · p.92 |
| Increased hepatic enzymes (ALT, AST, ALP) of >=1 CTC grade (FASLODEX) | >15 % of patients | FASLODEX · p.16 |
| Grade ≥ 3 AE (pooled, fulvestrant 250 mg) | 14.6 % | CONFIRM, NEWEST, FINDER 1, FINDER 2 Trials · p.89 |
Source: AstraZeneca PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →