PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019)
Pfizer Inc. · 2019 · 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, initially in 2015 and later expanding indications to include male patients. Efficacy was demonstrated in combination with letrozole (PALOMA-2) and fulvestrant (PALOMA-3), showing improved progression-free survival. Safety findings consistently highlight neutropenia and other hematologic abnormalities. Nonclinical studies in male rats revealed an increased incidence of microglial cell tumors at high doses, but the overall safety profile is considered consistent across genders. The approval was supported by clinical trials, real-world data, and comprehensive safety reviews.
Key findings — cited to the page
| Neutropenia (Grade 4) incidence (IBRANCE + letrozole) | 10 % | IBRANCE (palbociclib) in Study 1 (PALOMA-2) · p.13 |
| Infections (all grades) incidence (IBRANCE + letrozole) | 60 % | IBRANCE (palbociclib) in Study 1 (PALOMA-2) · p.13 |
| Neutropenia (all grades) incidence (IBRANCE + letrozole) | 80 % | IBRANCE (palbociclib) in Study 1 (PALOMA-2) · p.13 |
| Neutropenia (Grade 3) incidence (IBRANCE + letrozole) | 56 % | IBRANCE (palbociclib) in Study 1 (PALOMA-2) · p.13 |
| Rash (Grade 3) incidence (IBRANCE + fulvestrant) | 1 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Rash (Grade 4) incidence (IBRANCE + fulvestrant) | 0 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Decreased appetite (all grades) incidence (IBRANCE + fulvestrant) | 16 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Decreased appetite (Grade 3) incidence (IBRANCE + fulvestrant) | 1 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Decreased appetite (Grade 4) incidence (IBRANCE + fulvestrant) | 0 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Pyrexia (all grades) incidence (IBRANCE + fulvestrant) | 13 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Pyrexia (Grade 3) incidence (IBRANCE + fulvestrant) | <1 % | IBRANCE (palbociclib) in Study 2 (PALOMA-3) · p.15 |
| Infections (Grade 3) incidence (IBRANCE + letrozole) | 6 % | IBRANCE (palbociclib) in Study 1 (PALOMA-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 →