Palbociclib

(Ibrance®)

Ibrance®

Drug updated on 5/17/2024

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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  • Palbociclib (Ibrance) is indicated for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. It can be utilized in conjunction with an aromatase inhibitor as the initial endocrine-based therapy in postmenopausal women or men, and also combined with fulvestrant in patients who have disease progression following endocrine therapy.
  • Twenty-three systematic reviews/meta-analyses were analyzed to gather information about palbociclib's safety and effectiveness, especially when compared to other cyclin-dependent kinase 4/6 inhibitors such as abemaciclib and ribociclib.
  • The studies incorporated a diverse range of demographics including older patient populations, pre/perimenopausal women, postmenopausal women, which allowed for subgroup considerations during the analysis.
  • In terms of efficacy among older populations, palbociclib maintains quality without adversely impacting outcomes due to dose modifications. This highlights its effectiveness within this demographic that is often underrepresented in clinical trials.
  • When comparing palbociclib with other CDK4/6 inhibitors such as abemaciclib and ribociclib, no statistically significant difference was found regarding overall survival rates. However, differences were noted in adverse event profiles among these drugs, indirectly influencing patient compliance and treatment effectiveness.
  • Palbociclib has been shown across multiple studies to significantly improve Progression-Free Survival when used alongside fulvestrant or aromatase inhibitors for HR+/HER2- negative advanced/metastatic breast cancer patients, indicating comparable effectiveness against similar treatments using ribociclib or abemaciclib.
  • Regarding the safety profile; higher rates of neutropenia are associated with the use of palbociclib, but lower instances of gastrointestinal toxicities and serious events like diarrhea and liver toxicity, especially in comparison to abemaciclib.
  • Patient tolerability varies by population group; it appears that despite higher rates of neutropenia, it may be better tolerated in older populations due to the management of dose reductions and modifications.

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