Drug updated on 12/11/2024
| Dosage Form | Capsule (oral; 75 mg, 100 mg, 125 mg); Tablet (oral; 75 mg, 100 mg, 125 mg) |
| Drug Class | Kinase 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.
Latest News
Summary
- This summary is based on the review of 20 systematic review(s)/meta-analysis(es). [1-20]
- Palbociclib (Ibrance) combined with endocrine therapy (ET) significantly improved both progression-free survival (PFS) and overall survival (OS) in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor type 2 negative (HER2-) breast cancer, with findings consistent across randomized controlled trials (RCTs) and real-world evidence (RWE) studies. Comparative analyses noted ribociclib + ET improved OS more significantly than palbociclib + ET.
- Health-related quality of life (HRQoL) measures, including aspects like physical functioning, fatigue, and pain, were either maintained or improved in patients treated with palbociclib across multiple studies, including older adults and Asian patients, with outcomes favorable compared to ET alone.
- Palbociclib combined with ET achieved superior objective response rates (ORR) and disease control rates (DCR) relative to ET alone, indicating its robust therapeutic effect in managing HR+/HER2- advanced or metastatic breast cancer.
- Palbociclib's safety profile included a relatively high incidence of neutropenia, consistent with other cyclin-dependent kinases (CDK) 4/6 inhibitors, and a lower risk of QTc prolongation (relative risk (RR) 1.51) compared to ribociclib (RR 3.12), indicating fewer cardiovascular events compared to ribociclib and abemaciclib.
- Specific adverse events associated with palbociclib involved a lower incidence of diarrhea and fatigue than observed with abemaciclib, which had a higher rate of gastrointestinal toxicities; however, palbociclib presented an increased risk of stomatitis.
- In real-world settings, older patients receiving palbociclib experienced higher rates of dose modifications and treatment discontinuations, yet these adjustments did not adversely affect the drug's efficacy.
- Meta-analyses suggested that palbociclib, ribociclib, and abemaciclib each improved OS among AI-sensitive and AI-resistant patients, though palbociclib's OS improvement in AI-sensitive groups did not reach statistical significance (hazard ratio (HR) 0.83, 95% confidence interval (CI) [0.68-1.02]).
- Palbociclib demonstrated similar effectiveness and safety outcomes in older patients (≥ 65 years) compared to younger populations, maintaining HRQoL even with higher rates of dose modifications in the older cohort. Additionally, Asian patients receiving palbociclib experienced consistent improvements in HRQoL. Cardiovascular safety was a relevant factor, with palbociclib showing a lower risk of major adverse cardiovascular events (MACE) relative to other CDK4/6 inhibitors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ibrance (palbociclib) Prescribing Information. | 2023 | Pfizer Inc., New York, NY |