What is Palbociclib?
Palbociclib is a CDK4/6 inhibitor used in combination with hormone therapy (like Letrozole or Fulvestrant) to treat hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. It works by blocking the proteins (CDK4/6) that allow cancer cells to divide and grow.
Key Benefits:
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Slows progression of breast cancer significantly
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Works synergistically with hormone therapies
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Oral tablet — easy to administer at home
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Improves progression-free survival in advanced breast cancer patients
Available Strengths:
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Palbociclib 75mg Tablets
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Palbociclib 100mg Tablets
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Palbociclib 125mg Tablets
Mechanism of Action:
Palbociclib selectively inhibits cyclin-dependent kinases 4 and 6, thereby halting cancer cell cycle progression at the G1 phase.
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Indications:
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Advanced HR+ / HER2- breast cancer in postmenopausal women and men
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Used with aromatase inhibitors (e.g., Letrozole) or Fulvestrant
Administration Advice:
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Usually taken once daily for 21 days followed by 7 days off (28-day cycle)
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Dose adjustments may be required based on patient tolerance
Storage Instructions:
Store at room temperature (15–30°C), away from moisture and direct sunlight.
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References:-
European Medicines Agency (EMA)
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EMA – Ibrance (Palbociclib)
EPAR (European Public Assessment Report) detailing regulatory evaluation, therapeutic use, dosing, and safety information.
https://www.ema.europa.eu/en/medicines/human/EPAR/ibrance European Medicines Agency (EMA) -
EMA – Product-Specific Bioequivalence Guidance (Palbociclib)
Official technical guidelines for demonstrating bioequivalence of palbociclib formulations (including tablets and capsules).
https://www.ema.europa.eu/en/palbociclib-product-specific-bioequivalence-guidance European Medicines Agency (EMA)
U.S. Food & Drug Administration (FDA) & DailyMed
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FDA – Palbociclib (Ibrance) Approval Overview
FDA resource summarizing approval history, clinical trial basis (e.g. PALOMA-2, PALOMA-3), indications, and dosing regimen.
https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance U.S. Food and Drug Administration+1 -
DailyMed – Ibrance Label (Palbociclib Tablets)
Complete FDA-approved prescribing information including tablet strengths (75, 100, 125 mg), dosage, administration details, and safety precautions.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=559dd8e5-11f9-70cd-3fb0-9f9eb8484a37 Medicines.org.ukFDA Database
Additional Regulatory Reference
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Australia TGA – Palbociclib (Cipla’s Generic)
Official registration details in Australia for a generic version of palbociclib, including approval type and indications.
https://www.tga.gov.au/resources/prescription-medicines-registrations/cipla-palbociclib-cip-palbociclib-cipalon-cipla-australia-pty-lt
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