Palbociclib

(Ibrance®)

Ibrance®

Drug updated on 9/4/2024

Dosage FormCapsule (oral; 75 mg, 100 mg, 125 mg); Tablet (oral; 75 mg, 100 mg, 125 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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 in postmenopausal women or in men.
  • 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: Fulvestrant in patients with disease progression following endocrine therapy.

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Summary
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  • Ibrance (palbociclib) 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 in postmenopausal women or in men, and with Fulvestrant in patients with disease progression following endocrine therapy.
  • This summary is based on the review of 23 systematic review(s)/meta-analysis(es). [1-23]
  • Overall Survival (OS): CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) showed no statistically significant differences in OS, with similar benefits in advanced/metastatic breast cancer when combined with endocrine therapy. Palbociclib did not show a statistically significant hazard ratio (HR) for OS, unlike other CDK4/6 inhibitors.
  • Progression-Free Survival (PFS): Palbociclib, ribociclib, and abemaciclib significantly improved PFS when combined with endocrine therapy compared to placebo, with palbociclib ranking first in PFS outcomes in hormone receptor-positive/HER2-negative metastatic breast cancer.
  • Tumor Response and Clinical Benefit Rate: CDK4/6 inhibitors combined with endocrine therapy improved objective response rates and clinical benefit rates, with real-world evidence indicating palbociclib improved outcomes in HR+/HER2- advanced/metastatic breast cancer.
  • Specific Subgroup Analysis: Palbociclib showed similar efficacy in older patients (≥65 years) compared to younger patients, while ribociclib combined with endocrine therapy demonstrated significant efficacy in premenopausal women.
  • CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) were generally well-tolerated across studies, though specific adverse events varied among the drugs.
  • Palbociclib and ribociclib were associated with higher rates of neutropenia, while abemaciclib exhibited significantly higher gastrointestinal toxicity, including diarrhea.
  • Ribociclib had an increased incidence of hepatotoxicity and QTc prolongation, and abemaciclib had higher treatment discontinuation rates due to adverse events compared to palbociclib and ribociclib.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Ibrance (palbociclib-capsules) Prescribing Information.2023Pfizer labs., NY, NY
Ibrance (palbociclib-tablets) Prescribing Information.2023Pfizer labs., NY, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Palbociclib in older patients with advanced/metastatic breast cancer: a systematic review.2024Targeted Oncology
Comparative overall survival of CDK4/6 inhibitors in combination with endocrine therapy in advanced breast cancer.2024Scientific Reports
The likelihood of being helped or harmed as a patient-centred tool to assess cyclin dependent kinase 4/6 inhibitors clinical impact and safety in metastatic breast cancer: a systematic review and sensitivity-analysis.2023EClinicalMedicine
An overview of the safety profile and clinical impact of cdk4/6 inhibitors in breast cancer-a systematic review of randomized phase ii and iii clinical trials.2023Biomolecules
Safety profile of cyclin-dependent kinase (CDK) 4/6 inhibitors with concurrent radiation therapy: a systematic review and meta-analysis.2023Cancer Treatment Reviews
Second-line endocrine therapy of hormone receptor-positive/HER2-negative advanced breast cancer: a systematic review and network meta-analysis.2023Current Cancer Drug Targets
Health-related quality of life in breast cancer patients treated with CDK4/6 inhibitors: a systematic review.2022ESMO Open
Progression-free survival and overall survival of CDK 4/6 inhibitors plus endocrine therapy in metastatic breast cancer: a systematic review and meta-analysis.2022International Journal of Molecular Sciences
Neoadjuvant therapy of cyclin-dependent kinase 4/6 inhibitors combined with endocrine therapy in HR+/HER2- breast cancer: a systematic review and meta-analysis.2021Oncology Research and Treatment
CDK4/6 inhibitors in HR+/HER2- advanced/metastatic breast cancer: a systematic literature review of real-world evidence studies.2021Future Oncology
Oral adverse effects of CDK4/6 inhibitors among breast cancer patients: a systematic review and meta-analysis.2021Annals of Palliative Medicine
Emerging skin toxicities in patients with breast cancer treated with new cyclin dependent kinase 4/6 inhibitors: a systematic review.2021Drug Safety
Efficacy and safety of CDK4/6 and PI3K/AKT/mTOR inhibitors as second-line treatment in postmenopausal patients with hormone receptor-positive, HER-2-negative metastatic breast cancer: a network meta-analysis.2021Expert Opinion on Drug Safety
Comparison of endocrine therapies in hormone receptor-positive and human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: a network meta-analysis.2020Journal of Breast Cancer
Comparison of treatment-related adverse events of different cyclin dependent kinase 4/6 inhibitors in metastatic breast cancer: a network meta-analysis.2020Cancer Treatment Reviews
CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. a systematic review and meta-analysis.2020Expert Review of Anticancer Therapy
Endocrine therapies in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, pretreated, advanced breast cancer: a network meta-analysis.2020Medicine
Cyclin‑dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor‑positive breast cancer patients: a systematic review and meta‑analysis of randomized clinical trials.2020Cancer Treatment and Research
Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials.2020Breast Cancer Research and Treatment
Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis.2019The Lancet Oncology
Systematic literature review of clinical trials of endocrine therapies for premenopausal women with metastatic HR+ HER2- breast cancer.2019The Breast Journal
Treatment of advanced HR+/HER2- breast cancer with new targeted agents in combination with endocrine therapy: a review of efficacy and tolerability based on available randomized trials on everolimus, ribociclib, palbociclib and abemaciclib.2019Acta Oncologica
Comparative efficacy of CDK4/6 inhibitors plus aromatase inhibitors versus fulvestrant for the first-line treatment of hormone receptor-positive advanced breast cancer: a network meta-analysis.2019Targeted Oncology

Clinical Practice Guidelines