ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2019)
AstraZeneca PLC · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package for AstraZeneca's Faslodex (fulvestrant) Injection (NDA 021344) primarily concerns the November 9, 2012 approval of updated overall survival data from the Phase III CONFIRM study. This study compared 500 mg and 250 mg doses of fulvestrant in postmenopausal women with ER-positive advanced breast cancer, demonstrating improved efficacy with the 500 mg dose. The review also details clinical pharmacology, pharmacokinetics, and efficacy data from other studies. Concurrently, the report addresses significant carcinogenicity findings from mouse and rat studies, revealing dose-dependent ovarian tumors in female mice. These findings, along with safety data, are recommended for inclusion in the product labeling. The document also covers the regulatory review process, including exclusivity, patent information, and administrative details for this priority review supplement (S-020).
Key findings — cited to the page
| Increase in hepatic enzymes (AST, ALT, ALP) of >=1 CTC grade | >15 % of patients | FASLODEX · p.15 |
| Grade 3-4 increase in hepatic enzymes (AST, ALT, ALP) | 1-2 % of patients | FASLODEX · p.15 |
| Efficacy Supplement Type | SE8 (S-20) | Faslodex (fulvestrant) Injection · p.123 |
| NDA type | 505(b)(1), SE8 | Faslodex (fulvestrant) Injection · p.114 |
| NDA Supplement number | S-019 and S-020 | Faslodex (fulvestrant) Injection · p.123 |
| User Fee Goal Date | 12/28/12 | Faslodex (fulvestrant) Injection · p.123 |
| Supplement number | s-020 | Faslodex (fulvestrant) Injection · p.111 |
| NDA number | 021344 | Faslodex (fulvestrant) Injection · p.111 |
| PDUFA target action date | December 7, 2012 | Faslodex (fulvestrant) Injection · p.111 |
| Review priority | Priority | Faslodex (fulvestrant) Injection · p.111 |
| Applicant | AstraZeneca | · p.46 |
| PDUFA Date | December 28, 2012 | Faslodex (fulvestrant) Injection · p.111 |
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 →