Drug updated on 5/2/2024
| 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.
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.
- A total of 25 systematic reviews and meta-analyses were reviewed to gather information about this drug's effectiveness and safety profile.
- When combined with endocrine therapy, palbociclib significantly improves progression-free survival and overall survival in patients compared to those receiving endocrine therapy alone.
- Compared to other cyclin-dependent kinase 4/6 inhibitors such as ribociclib and abemaciclib, palbociclib shows similar effectiveness in improving patient outcomes but may have minor differences based on indirect comparisons using SUCRA values.
- Specific population subgroups like postmenopausal women or those who have progressed after prior endocrine therapy also benefit from combinations involving palbociclib; its efficacy remains consistent across various demographics and disease severities.
- Neutropenia is a significant concern associated with CDK4/6 inhibitors including palbociclib; however, rates of severe neutropenia vary among these drugs - while often cited for notable incidence with Ibrance use it isn't necessarily higher than that seen with ribocilib usage whereas abemaciclic has lower rates but higher instances of diarrhea side effects.
- Adverse events reported for Ibrance generally include hematologic toxicities (notably neutropenia), fatigue, nausea, alopecia etc., yet discontinuation due to adverse events are lower when compared against chemotherapy agents & comparable/favorable when pitted against other CDK4/6is.
- Economic evaluations indicate that despite their clinical benefits the high costs associated with CDK4/6is including Ibrance pose challenges towards widespread accessibility & utility – comparatively speaking Ribcilib plus Letrozole might offer slightly better economic benefits over Ibrance plus Letrozole in specific settings.
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 |