IBRANCE (palbociclib)
IBRANCE is indicated for the treatment of 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.
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
- Patent Cliff
- 2037
- Revenue
- $1.0B (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
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 Target & Pathway
ProTarget
IBRANCE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IBRANCE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IBRANCE treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
186 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT05554367 | NCI-2022-07266 NCI-2022-07266, EAY191-A3 | Ph 2 | active not recruiting | Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial |
| NCT06377852 | Pro00075309 | Ph 3 | recruiting | The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study |
| NCT06126276 | NCI-2023-09270 NCI-2023-09270, EAY191-N5 | Ph 2 | recruiting | Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial) |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT07405164 | 6482-043 U1111-1325-4582, 2025-524160-38-00 | Ph 3 | recruiting | Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) |
| NCT03609047 Appalaches | EORTC 1745-ETF-BCG | Ph 2 | active not recruiting | Adjuvant Palbociclib in Elderly Patients With Breast Cancer |
| NCT04802759 | CO42867 2020-004889-19, 2023-507495-48-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer |
| NCT05694871 | A092107 NCI-2022-08568 | Ph 2 | active not recruiting | Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma |
| NCT06188520 CYCAD-1 | D8470C00001 | Ph 1, Ph 2 | recruiting | A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors |
| NCT06065748 | CO44657 2022-502980-39-00 | Ph 3 | recruiting | A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) |
| NCT03155620 results posted | NCI-2017-01251 NCI-2017-01251, APEC1621SC | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) |
| NCT02942355 | IRB00081369 00017766, LCI-BRE-H2N-ANPA-001 | Ph 2 | active not recruiting | Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer |
| NCT03633331 results posted | A171601 NCI-2017-01596 | Ph 2 | completed | Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer |
| NCT07174336 | 27726 J6M-MC-JSGD, 2025-522791-92-00 | Ph 3 | recruiting | A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) |
| NCT03784014 MULTISARC | C16-40 2024-514873-22-00, 2017-002851-27 | Ph 3 | completed | Molecular Profiling of Advanced Soft-tissue Sarcomas |
| NCT02664935 | RG_14-072 2014-000814-73, ISRCTN38344105 | Ph 2 | completed | National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer |
| NCT07492641 KANDELA-302 | BGB-43395-302 2025-523960-19-00 | Ph 3 | not yet recruiting | BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease |
| NCT05768139 PIKALO-1 | 27691 2023-504807-94-00, 2023-000442-41 | Ph 1, Ph 2 | recruiting | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors |
| NCT05683418 | TOS-358-001 2023-505346-26-01 | Ph 1 | recruiting | A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer |
| NCT04964934 SERENA-6 | D8534C00001 2023-503990-39-00, 2021-000546-17 | Ph 3 | active not recruiting | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) |
| NCT03389477 results posted | 201802162 | Ph 2 | active not recruiting | Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma |
| NCT06997029 | CA243-0001 2025-524334-26-00, U1111-1330-3304 | Ph 1 | recruiting | A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors |
| NCT04862663 CAPItello-292 | D361DC00001 2020-004637-20 | Ph 3 | recruiting | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) |
| NCT04966481 | 202108203 | Ph 3 | recruiting | Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor |
| NCT04996160 | IRB-60392 NCI-2021-09313 | Ph 1 | completed | Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia |
| NCT04606446 KAT6 | C4551001 NCT04606446 | Ph 2 | recruiting | Study of PF-07248144 in Advanced or Metastatic Solid Tumors |
| NCT03132454 | 2016-0772 NCI-2018-01194, 2016-0772 | Ph 1 | active not recruiting | Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia |
| NCT05238922 | INCB 123667-101 2021-005357-91 | Ph 1 | recruiting | Study of INCB123667 in Subjects With Advanced Solid Tumors |
| NCT06380751 EvoPAR-BR01 | D9722C00001 | Ph 3 | recruiting | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer |
| NCT04439201 results posted | NCI-2020-03171 NCI-2020-03171, EAY131-Z1B | Ph 2 | active not recruiting | Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B) |
| NCT02159755 | NCI-2014-01202 NCI-2014-01202, 1403014853 | Ph 1 | active not recruiting | Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma |
| NCT06390839 results posted | NCI-2024-01137 NCI-2024-01137, EAY131-Z1C | Ph 2 | active not recruiting | Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C) |
| NCT04841148 PALAVY | UPCC 01121 IRB# 848471, TBCRC 046 | Ph 2 | recruiting | Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer |
| NCT03478514 | AFT-32 | Ph 2 | active not recruiting | Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma |
| NCT04360941 PAveMenT | CCR4884 | Ph 1 | recruiting | PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer |
| NCT03526250 results posted | NCI-2018-00863 NCI-2018-00863, APEC1621I | Ph 2 | completed | Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) |
| NCT02693535 TAPUR | Pro00014171 | Ph 2 | recruiting | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT05039177 HERKULES-3 | ERAS-007-03 | Ph 1, Ph 2 | completed | A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies |
| NCT07123090 SPARCC | 25-258 | Ph 2 | recruiting | A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma |
| NCT03573648 ImmunoADAPT | J1836 IRB00164275, WI231034 | Ph 2 | active not recruiting | Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer |
| NCT04191499 INAVO120 results posted | WO41554 2019-002455-42, 2023-505812-39-00 | Ph 2, Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer |
| NCT03424005 Morpheus-panBC | CO40115 2017-002038-21, 2023-503629-20-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer |
| NCT06843967 | 24-344 | Ph 1, Ph 2 | recruiting | A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma |
| NCT06736704 | SNV4818-101 | Ph 1, Ph 2 | recruiting | SNV4818 in Participants With Advanced Solid Tumors |
| NCT02896335 | 16-254 | Ph 2 | recruiting | Palbociclib and Pembrolizumab In Central Nervous System Metastases |
| NCT05627232 | 22G.769 JT 24252, 4100095617 | Ph 1 | recruiting | Tazemetostat and Palbociclib With CPX-351for R/R AML |
| NCT03006172 | GO39374 2016-003022-17, 2023-508124-36-00 | Ph 1 | active not recruiting | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer |
| NCT03446157 results posted | LCCC1717 | Ph 2 | completed | Palbociclib and Cetuximab in Metastatic Colorectal Cancer |
Showing 50 of 186 trials
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
Indications & Usage
FDA Label (PDF)IBRANCE is indicated for the treatment of 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 Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for IBRANCE
Revenue Insights
- • Q4-2025: $1.0B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 90 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.