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|Marketing Authorisation Holder||Pfizer Limited|
|Mode of Action||Kinase inhibitor (chemotherapy)|
|Regulatory agency approval||European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia|
Palbociclib is indicated for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease1. It is indicated in combination with an aromatase inhibitor (an hormonal therapy) as initial endocrine based therapy in postmenopausal women or fulvestrant in women with disease progression following endocrine therapy1,8.
Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. Before a cell can divide, it has to go through four phases. The first phase is a growth phase (G1-phase), the second a synthesis phase (S-phase), the third another growth phase (G2-phase) and the last phase, where the cell divides (M-phase). Cancer cells divide exceedingly fast, passing through these 4 phases rapidly. Palbociclib blocks the progression from the first G1-phase, into the second S-phase. It does this by inhibiting the cyclin-dependent kinases 4 and 6 (CDK4 and CDK6)—two proteins that are involved in entering the S-phase1.
Palbociclib was approved by:
for use in combination with an aromatase inhibitor (e.g. letrozole) or with fulvestrant for the treatment of women with HR+/HER2- locally advanced or metastatic breast cancer who have received prior endocrine therapy.
The standard dosage is:
125 mg daily for 21 consecutive days, followed by 7 days of treatment with letrozole 2.5 mg daily continuously throughout the 28-day cycle1,8.
Complete information about palbociclib dosage and administration can be found in the resources section.
Consult your treating doctor for personalised dosing.
Most common adverse reactions with palbociclib are3,5: