ASTRAZENECA — Faslodex FDA Review (NDA/BLA 021344, 2018)
AstraZeneca PLC · 2018 · FDA Review (Drugs@FDA) · company profile →
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This FDA approval package details AstraZeneca's Faslodex (fulvestrant) injection, approved March 2, 2016, for HR-positive metastatic breast cancer. It's indicated as monotherapy and in combination with palbociclib for HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. Clinical trials, particularly PALOMA-3 (Study 1023), demonstrated significant improvements in progression-free survival (PFS) for the 500mg dose and in combination with palbociclib. While overall survival data remained immature, secondary endpoints like objective response rate and clinical benefit rate also favored the combination. The safety profile showed neutropenia as a common adverse event, often managed with dose modifications. The regulatory review involved extensive correspondence, including a pediatric waiver and label updates.
Key findings — cited to the page
| Increased hepatic enzymes (AST, ALT, ALP) post-baseline ≥1 CTC grade | >15 % of patients | · p.15 |
| Increased hepatic enzymes (AST, ALT, ALP) Grade 3-4 | 1-2 % of patients | · p.15 |
| rate of Grade 3/4 leukopenia in palbociclib plus fulvestrant arm | 31 % | · p.124 |
| Grade 3-4 TEAEs associated with dose reduction in palbociclib plus fulvestrant arm (N=345) | 105 | · p.123 |
| rate of Grade 3 neutropenia in palbociclib plus fulvestrant arm | 56 % | · p.124 |
| rate of Grade 4 neutropenia in palbociclib plus fulvestrant arm | 11 % | · p.124 |
| all grades infections in placebo plus fulvestrant arm (N=172) | 30.8 % | Study 1023 · p.124 |
| Grade 3-4 TEAEs associated with dose reduction in placebo plus fulvestrant arm (N=172) | 1 | · p.123 |
| Grade 4 neutropenia associated with palbociclib dose reduction | 15 | · p.123 |
| Grade 4 neutrophil count decreased associated with palbociclib dose reduction | 4 % | · p.123 |
| rate of Grade 3/4 neutropenia in palbociclib plus fulvestrant arm | 66 % | · p.123 |
| rate of Grade 3 leukopenia in palbociclib plus fulvestrant arm | 30 % | · p.124 |
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 →