PFIZER — Ibrance FDA Summary Review (NDA/BLA 207103, 2015)
Pfizer Inc. · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Pfizer's Ibrance (palbociclib) in combination with letrozole for ER-positive, HER2-negative advanced breast cancer. This accelerated approval was based on significant progression-free survival (PFS) improvement observed in the PALOMA-1 trial, despite some study design limitations. A confirmatory trial (PALOMA-2) is ongoing. The drug's safety profile was acceptable, with neutropenia and infections being the most common adverse events.
Key findings — cited to the page
| Grade 3 or 4 infections (IBRANCE + letrozole) | 5 % | PALOMA-1 · p.14 |
| median investigator-assessed PFS | 20.2 months | PALOMA-1 · p.3 |
| PFS Hazard Ratio for letrozole vs tamoxifen | 0.72 | · p.4 |
| PFS Hazard Ratio | 0.488 | PALOMA-1 · p.3 |
| median PFS for letrozole vs tamoxifen | 9.4 months | · p.4 |
| median PFS for tamoxifen | 6 months | · p.4 |
| median investigator-assessed PFS (control arm) | 10.2 months | PALOMA-1 · p.3 |
| PALOMA-1 Phase 2 initial enrollment target | 150 patients | PALOMA-1 · p.6 |
| PALOMA-1 Part 1 enrollment target | 60 patients | PALOMA-1 · p.6 |
| PALOMA-1 Part 2 enrollment target | 150 patients | PALOMA-1 · p.6 |
| PALOMA-1 Part 2 accrued patients | 99 patients | PALOMA-1 · p.7 |
| Investigator-assessed PFS Part 2 Hazard Ratio | 0.508 | PALOMA-1 · p.9 |
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 →