NDAORALCAPSULEPriority Review
Approved
Feb 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
IBRANCE (palbociclib) by Pfizer is kinase inhibitors [moa]. Approved for breast cancer, liposarcoma. First approved in 2015.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IBRANCE (palbociclib) is an oral cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved in 2015 for hormone receptor-positive, HER2-negative breast cancer in combination with endocrine therapy. It works by blocking cell cycle progression in cancer cells, slowing tumor growth and extending survival in advanced disease.
Peak8.3 years to LOE
IBRANCE remains at peak commercial maturity with sustained market presence, though team expansion is limited as the product approaches the later stages of its lifecycle.
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications (2)
Clinical Trials (20)
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
Started Nov 2025
25 enrolled
Metastatic Renal Cell CarcinomaMetastatic Renal CancerRenal Cell Carcinoma+3 more
A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database
Started Jun 2025
1 enrolled
Advanced or Metastatic Breast Cancer
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Started Feb 2025
54 enrolled
Well Differentiated LiposarcomaDedifferentiated LiposarcomaLiposarcoma+6 more
A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
Started Jan 2025
1,772 enrolled
Breast Neoplasms
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
Started Aug 2024
733 enrolled
Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.