IBRANCE
Ibrance (palbociclib) is a kinase inhibitor indicated for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is used in combination with an aromatase inhibitor as initial endocrine-based therapy or with fulvestrant in patients whose disease has progressed following endocrine therapy. Additionally, it is approved for use with inavolisib and fulvestrant to treat patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer. This therapeutic provides a targeted approach for specific molecular subtypes of breast cancer following recurrence or progression.
How IBRANCE Works
Palbociclib functions as an inhibitor of cyclin-dependent kinases (CDK) 4 and 6, which are enzymes that regulate the cellular signaling pathways responsible for cell proliferation. By blocking these kinases, the drug prevents cancer cells from progressing from the G1 phase into the S phase of the cell cycle, effectively halting cell division. This inhibition reduces the phosphorylation of the retinoblastoma (Rb) protein, leading to decreased downstream signaling and increased growth arrest. When used in combination with antiestrogens, the drug further increases cell senescence and tumor growth inhibition compared to single-agent treatment.
Details
- Status
- Prescription
- First Approved
- 2015-02-03
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
IBRANCE Approval History
What IBRANCE Treats
3 indicationsIBRANCE is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy
- Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in patients with disease progression following endocrine therapy
- Endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with inavolisib and fulvestrant following recurrence on or after completing adjuvant endocrine therapy
IBRANCE Competitors
Pro3 other drugs also target CDK4. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CDK4). Earlier expiry dates signal biosimilar/generic opportunities.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IBRANCE FDA Label Details
ProIndications & Usage
FDA Label (PDF)IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy; or • fulvestrant in patients with disease progression following endocrine therapy. IBRANCE is indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-appr...
IBRANCE Patents & Exclusivity
Patents (90 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.