NDAORALCAPSULEPriority Review
Approved
Feb 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
IBRANCE (palbociclib) by Pfizer is kinase inhibitors [moa]. First approved in 2015.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IBRANCE (palbociclib) is an oral small-molecule CDK4/6 kinase inhibitor approved by the FDA in 2015 for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. It works by inhibiting cyclin-dependent kinases 4 and 6, which are key regulators of cell cycle progression, thereby halting cancer cell proliferation. The drug is typically administered in combination with endocrine therapy.
Peak7.9 years to LOE
Peak-stage product indicates stable commercial operations with established market presence; brand team size likely mature with focus on line extension and retained market share.
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Started Oct 2026
40 enrolled
Breast CancerDiabetes Type II
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
95,637 enrolled
Breast Neoplasms
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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.