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 details AstraZeneca's Type II variation application for Faslodex (fulvestrant) to extend its indication for use in combination with palbociclib for HR-positive, HER2-negative locally advanced or metastatic breast cancer, particularly in women who have received prior endocrine therapy. The application is supported by the Phase 3 PALOMA-3 (Study 1023) trial, which compared fulvestrant plus palbociclib against fulvestrant plus placebo. The study demonstrated a statistically significant and clinically meaningful improvement in progression-free survival for the palbociclib combination, with favorable secondary endpoints. The safety profile was manageable, primarily characterized by myelosuppression, especially neutropenia. The CHMP concluded a positive benefit-risk balance, recommending the variation for this new indication.
Key findings — cited to the page
| Grade 4 Neutrophil count decreased (palbociclib + fulvestrant arm) | 3.5 % | Study 1023 (PALOMA-3) · p.42 |
| Grade 3 Neutropenia (palbociclib + fulvestrant arm) | 42.6 % | Study 1023 (PALOMA-3) · p.42 |
| Grade 3 leukopenia | 64 % | Study 1023 (PALOMA-3) · p.41 |
| Grade 4 Neutropenia (palbociclib + fulvestrant arm) | 7.2 % | Study 1023 (PALOMA-3) · p.42 |
| Patients with Grade 3 treatment-related AEs (palbociclib + fulvestrant arm) | 203 | Study 1023 (PALOMA-3) · p.42 |
| Patients with Grade 3 treatment-related AEs (placebo + fulvestrant arm) | 8 | Study 1023 (PALOMA-3) · p.42 |
| Grade 3 neutropenia | 67 % | Study 1023 (PALOMA-3) · p.41 |
| Grade 3 neutrophil count decreased | 63 % | Study 1023 (PALOMA-3) · p.41 |
| Patients with Grade 4 treatment-related AEs (palbociclib + fulvestrant arm) | 38 | Study 1023 (PALOMA-3) · p.42 |
| Patients with Grade 4 treatment-related AEs (placebo + fulvestrant arm) | 2 | Study 1023 (PALOMA-3) · p.42 |
| Grade 4 White blood cell count decreased (palbociclib + fulvestrant arm) | 0.6 % | Study 1023 (PALOMA-3) · p.42 |
| Grade 3 Neutrophil count decreased (palbociclib + fulvestrant arm) | 14.2 % | Study 1023 (PALOMA-3) · p.42 |
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 →