PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2018)
Pfizer Inc. · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Pfizer's Ibrance (palbociclib) for HR-positive, HER2-negative advanced or metastatic breast cancer. The approval package details its indications, dosage, and safety warnings, including common adverse reactions like neutropenia and pulmonary embolism. Clinical trials, particularly PALOMA-3 (Study 1023), demonstrated significant improvement in progression-free survival when Ibrance was combined with fulvestrant. The review confirmed Ibrance's efficacy and safety profile, leading to regular approval. Postmarketing commitments include a final overall survival analysis. The regulatory process involved extensive review of clinical, nonclinical, and pharmacokinetic data, drug-drug interactions, and pediatric assessment waivers, ultimately granting three-year exclusivity.
Key findings — cited to the page
| Grade ≥3 decrease in neutrophil counts | 66 % | Study 2 (IBRANCE + fulvestrant) · p.13 |
| Dose reductions due to adverse reaction (any grade) | 36 % | Study 2 (IBRANCE + fulvestrant) · p.16 |
| Grade ≥3 decrease in neutrophil counts | 62 % | Study 1 (IBRANCE + letrozole) · p.13 |
| Hemoglobin decreased (Grade 3) | 5 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Platelets decreased (Grade 3) | 3 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Platelets decreased (Grade 4) | 0 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Lymphocytes decreased (Grade 4) | 1 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Hemoglobin decreased (Grade 4) | 1 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Lymphocytes decreased (Grade 3) | 17 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Hemoglobin decreased (all grades) | 83 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Platelets decreased (all grades) | 61 % | Study 1 (IBRANCE + letrozole) · p.16 |
| Median time to first episode of any grade neutropenia | 15 days | Study 1 and 2 · p.13 |
Source: Pfizer Inc. ↗ · 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 →