Ibrance (palbociclib)

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Ibrance (palbociclib)

How to buy Ibrance (palbociclib): You can order Ibrance (palbociclib) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide.

Oncology Breast Cancer
Marketing Authorisation Holder Pfizer Limited
Mode of Action Kinase inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Package 21 Capsules

What is Ibrance (palbociclib) for?

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.

How does Ibrance (palbociclib) work?

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.

Is Ibrance (palbociclib) approved?

Palbociclib was approved by:

  • Food and Drug Administration (FDA), USA:
    • February 3, 2015, for use in combination with letrozole 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 disease2. 
    • On March 31, 2017, the accelerated approval was converted into a regular approval for use 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.
  • European Medical Agency (EMA), European Union,  November 11, 20164 

and

  • Therapeutic Goods Administration (TGA), Australia, May 3, 201711 

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.

How do I take Ibrance (palbociclib)?

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.

Common adverse reactions or side effects of Ibrance (palbociclib)

Most common adverse reactions with palbociclib are3,5:

  • neutropenia
  • leukopenia
  • fatigue
  • anemia
  • infection
  • nausea
More Information
Working ingredient palbociclib
Shipping method Standard (not temperature controlled)
Package 21
Therapeutic Area Oncology
Oncology Breast Cancer
Indication Estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer
Administration Oral
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
Marketing Authorisation Holder Pfizer Limited

The efficacy of palbociclib on ER-positive, HER2-negative, advanced breast cancer was investigated in three main studies named PALOMA-1, PALOMA-2, and PALOMA-3.

PALOMA-1 was a randomised, multicentre, open-label trial in postmenopausal women with ER-positive, HER2-negative, advanced (locally advanced or metastatic) breast cancer who had not received previous systemic treatment for advanced disease. The trial enrolled 165 patients randomly allocated to receive either palbociclib (125 mg orally daily for 21 consecutive days, followed by 7 days off treatment) plus letrozole (2.5 mg daily continuously throughout the 28-day cycle) or letrozole alone. The progression-free survival (PFS) was 20.2 months in the palbociclib plus letrozole arm and 10.2 months in the letrozole alone arm. Overall response rate in patients with measurable disease was higher in the palbociclib plus letrozole compared to the letrozole alone arm (55.4% versus 39.4%)3.

PALOMA-2 involved 666 untreated women. They received either palbociclib and letrozole (an aromatase inhibitor) or placebo and letrozole. The median PFS in women taking palbociclib and letrozole was on average 24.8 months (95% CI 22.1, non-estimable)1,8 compared with 14.5 months (95% CI 12.9, 17.1)1,8 for women taking placebo and letrozole5,10.

PALOMA-3 involved 521 women who received either palbociclib and fulvestrant or a placebo and fulvestrant. The median PFS in women taking palbociclib and fulvestrant was 9.5 months (95% CI 9·2–11·0) compared with 4.6 months (95% CI 3·5–5·6) for women taking placebo and fulvestrant9.

In March 2017 the German Institute for Quality and Efficiency in Health Care raised its doubts regarding the added benefit of palbociclib6,7.


1. Summary of Product Characteristics [FDA]: Ibrance (palbociclib) [PDF]
    Pfizer Inc., Mar 2017

2. FDA Approved Drugs. Palbociclib
    FDA, cited Sept 2015

3. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as      first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-     1/TRIO-18): a randomised phase 2 study
     Finn R.S., et al. The Lancet Oncology, Jan 2015

4. Ibrance (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2-     Metastatic Breast Cancer
    Pfizer, Nov 2016

5. Human Medicines: Ibrance (palbociclib)
    EMA, cited Nov 2016

6. IQWiG finds no added benefit for breast cancer drug Ibrance
    The pharma letter, March 2017

7. Palbociclib in advanced breast cancer: Disadvantages predominate in certain patients
    IQWiG, March 2017

8. Summary of Product Characteristics [EMA]: Ibrance (palbociclib) [PDF]
    Pfizer Ltd., May 2017

9. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial
    Cristofanilli M., et al., The Lancet Oncology, April 2016

10. PALOMA-2: Primary Results From a Phase III Trial of Palbociclib Plus Letrozole Compared With Placebo Plus Letrozole in Postmenopausal Women With ER+/HER2- Advanced Breast Cancer.
      Finn R.S., et.al. , ASCO University: Meeting Library. June 2016

11. Summary of Product Characteristics [TGA]: Ibrance (palbociclib) [PDF]
      Pfizer Australia Ltd., May 2017  


Shipping Type Standard
Shipping method Standard (not temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.