Drug updated on 9/4/2024
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
- 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 Title | Year | Source |
---|---|---|
Ibrance (palbociclib-capsules) Prescribing Information. | 2023 | Pfizer labs., NY, NY |
Ibrance (palbociclib-tablets) Prescribing Information. | 2023 | Pfizer labs., NY, NY |