This reference hub prioritizes regulatory agencies, official prescribing information and peer-reviewed clinical evidence.
Regulatory Sources
U.S. Food and Drug Administration
FDA approval information provides current U.S. regulatory developments, including the June 2026 approval of palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for maintenance treatment in HR-positive/HER2-positive locally advanced or metastatic breast cancer following induction treatment.
DailyMed
DailyMed provides current U.S. IBRANCE labeling, including indications, dosing, strengths, warnings, interactions and pharmacology.
European Medicines Agency
The EMA Ibrance EPAR provides European authorization information and identifies Pfizer Europe MA EEIG as the marketing authorization holder for Ibrance in the European Union.
Clinical evidence
PALOMA-2 evaluated palbociclib plus letrozole in previously untreated postmenopausal patients with ER-positive/HER2-negative advanced breast cancer.
PALOMA-3 evaluated palbociclib plus fulvestrant in patients with HR-positive/HER2-negative advanced breast cancer following endocrine treatment.
PATINA evaluated palbociclib with anti-HER2 therapy and endocrine therapy in HR-positive/HER2-positive metastatic breast cancer after induction treatment.
Reference-product history
Pfizer announced the original U.S. FDA approval of IBRANCE in February 2015.
Palbocent-specific documentation
Specific manufacturer, authorization, distributor and authentication documentation for Palbocent is: