PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019)
Pfizer Inc. · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA review of Pfizer's Ibrance (palbociclib) for HR-positive, HER2-negative advanced or metastatic breast cancer led to its approval and expanded indication for use with any aromatase inhibitor. Clinical trials, particularly PALOMA-2 (Study 1008) and PALOMA-3 (Study 2), demonstrated significant improvements in progression-free survival when Ibrance was combined with letrozole or fulvestrant. The safety profile, primarily characterized by manageable neutropenia, was consistent across studies. Nonclinical and clinical pharmacology data supported the drug's efficacy and safety, with no new concerns identified. Labeling recommendations, postmarketing commitments, and detailed safety assessments, including QT interval analysis, were also part of the comprehensive review.
Key findings — cited to the page
| Anemia (Grade 3) | 5 % | IBRANCE plus Letrozole · p.16 |
| Anemia (Grade 4) | <1 % | IBRANCE plus Letrozole · p.16 |
| Leukopenia (all grades) | 2 % | Placebo plus Letrozole · p.16 |
| Anemia (all grades) | 24 % | IBRANCE plus Letrozole · p.16 |
| Vomiting (all grades) | 17 % | Placebo plus Letrozole · p.16 |
| Alopecia (all grades) | 16 % | Placebo plus Letrozole · p.16 |
| Nausea (all grades) | 35 % | IBRANCE plus Letrozole · p.16 |
| Leukopenia (Grade 4) | 1 % | IBRANCE plus Letrozole · p.16 |
| Leukopenia (Grade 3) | 0 % | Placebo plus Letrozole · p.16 |
| Leukopenia (Grade 4) | 0 % | Placebo plus Letrozole · p.16 |
| Alopecia (all grades) | 33 % | IBRANCE plus Letrozole · p.16 |
| Anemia (all grades) | 9 % | Placebo plus Letrozole · p.16 |
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 →