Drug updated on 5/17/2024
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.
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Summary
- 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 Title | Year | Source |
---|---|---|
Ibrance (palbociclib-capsules) Prescribing Information. | 2023 | Pfizer labs., NY, NY |
Ibrance (palbociclib-tablets) Prescribing Information. | 2023 | Pfizer labs., NY, NY |