Ibrance (palbociclib)

100 % legal and regulated
Secured logistics globally
24/7 track & trace delivery
Safe payment by bank transfer or credit card

We are registered as an independent intermediary for medicines with the Dutch Ministry of Health

Ibrance (palbociclib)

How to buy Ibrance: You can order Ibrance (palbociclib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Pfizer
Disease Breast Cancer
Indication ER-positive HER2-negative advanced breast cancer
Mode of Action Kinase inhibitor (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 571190-30-2
HS Code 29337900
Strength 75 mg, 125 mg, 100 mg

Who is 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 disease [1]. 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 therapy [1][8].

Recommended dose

Complete information about palbociclib dosage and administration can be found here [1][8].
The standard dosage is:
  • 125 mg daily for 21 consecutive days, followed by 7 days off treatment with letrozole 2.5 mg daily continuously throughout the 28-day cycle [1][8].
Consult your treating doctor for personalised dosing.

What is palbociclib and how does it 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-phase [1].

What is palbociclib's approval status?

Palbociclib was approved by
  • FDA (USA) on 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 disease [2]. 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 therapy [1][8].
  • EMA (EU) on November 11, 2016 [4],
  • TGA (AUS) on May 3, 2017 [11],
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 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 letrozole [5][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 fulvestrant [9].
Most common adverse reactions with palbociclib are neutropenia, leukopenia, fatigue, anemia, and infection, nausea [3][5].
In March 2017 the German Institute for Quality and Efficiency in Health Care raised its doubts regarding the added benefit of palbociclib [6][7].
[1] Summary of Product Characteristics: Ibrance (palbociclib), Pfizer Inc., FDA, Mar. 2017.
[2] FDA Approved Drugs. Palbociclib, 03/02/2015, cited on 30/09/2015.
[3] Finn R.S., et al. 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. The Lancet Oncology. 2015 Jan; 16(1):25-35
[4] Pfizer Press Release: Ibrance (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer, 10/11/2016.
[5] EMA. Human Medicines: Ibrance (palbociclib), 25/11/2016 , cited on 30/11/2016.
[6] IQWiG finds no added benefit for breast cancer drug Ibrance. The pharma letter. 04/03/2017.
[7] Palbociclib in advanced breast cancer: Disadvantages predominate in certain patients. IQWiG. 01/03/2017.
[8] Summary of Product Characteristics: Ibrance (palbociclib), Pfizer Ltd., FDA, May 2017.
[9] Cristofanilli M., et al. 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. The Lancet Oncology, 2016 Apr; 17(4):425-439.
[10] Finn R.S., et.al. 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. ASCO University: Meeting Library. 2016 Jun.
[11] Summary of Product Characteristics: Ibrance (palbociclib), Pfizer Australia Ltd., TGA, May 2017.

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.

How can we help?

★ ★ ★ ★ ★

We've received requests for support from patients and doctors in over 120 countries, and delivered medicines to 6 continents. They've given us a 5 star rating for our service. Read what our friends from around the world are saying...

"My experience has been excellent. TheSocialMedwork were totally knowledgeable about the medicine I was looking for, and how to get it delivered to me quickly and easily. I UNCONDITIONALLY recommend TSM to anyone, it is truly a world-class organisation."

— Charles, USA

"During the transaction process I was very well informed by TheSocialMedwork team. They have put so much effort to ensure the best service was offered to me. Moreover the medicine I ordered was imported two weeks earlier. I highly recommend TheSocialMedwork."

— Tomasz, Poland

"I hope you know how needed you are and what it means to get a prompt, succinct and helpful reply. You are our hero. You have given us realistic hope in obtaining needed drugs in a timely way."

— Regina, US

"TheSocialMedwork were so helpful in getting the right medication to me, expediting its delivery, and keeping in touch. They simply can't do enough to help you. I would not hesitate to recommend TheSocialMedwork to anybody. Lovely people."

— Stephen, UK

"Totally awesome! Keep up the great work you're doing!"

— Dee, Australia

"When the doctor tells you that there are no treatments left to try, search further - there may be new treatments in other countries."

— Charlotte, The Netherlands

"TheSocialMedwork's professional capabilities, kindness and patience deserve our gratitude and respect."

— Haoyu, China

"My daughter died at the age of 21 because she couldn't get the treatment that might have saved her life. Now TheSocialMedwork might be able to help people like Abigail to get the best treatment."

— Frank, Virginia, USA

"The team is highly professional, friendly and will take care of everything. More options for doctor and patients. This service is transparent, unique and necessary. Keep it up!"

— Pa Tric, Germany

"Excellent communication and clarifications given every time when requested. They also provide fantastic support and updates from the start till the end of the process of the medicine provisioning."

— Milos, Serbia & Montenegro

Registered with the Dutch Ministry of Health as an independent intermediary, Registration number 6730 BEM
Registered as a USA Delaware LLC.

Our service uses cookies.