The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain. IBRANCE® (palbociclib) Prescribing Information for Great Britain click here. IBRANCE® (palbociclib) Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
Confidence Through Experience11-19
IBRANCE (palbociclib) has >4 years of real-world experience, and there is a growing body of RWE both in the UK and globally to support the use of palbociclib11-13
Real-world palbociclib patient populations and subgroups (including patients with visceral disease) achieved outcomes that complement those demonstrated across the PALOMA RCTs11-17
In the IRIS UK study, 9 out of 10 patients were alive at 2 years (weighted with median patient numbers**):11
- 92.2% in first-line (palbociclib + AI) at 24 months
- 85.2% in second-line (palbociclib + fulvestrant) at 24 months
** Timeframe >24 months where follow-up available. Survival rate defined as time from the date of initiation of IBRANCE® combination therapy to the date of death due to any cause or end of follow-up (if earlier). 255 patients in the IRIS UK cohort: 221 patients received IBRANCE® plus AI, survival rate 92.2%; 34 patients received IBRANCE® plus fulvestrant: survival rate 85.2%, the calculated weighted average is 91.3%.
In P-REALITY, patients treated with IBRANCE plus letrozole demonstrated significant improvement in rwPFS and OS compared with patients who received letrozole alone: median OS was not reached for patients receiving IBRANCE plus letrozole and was 43.1 months with letrozole alone†13
First-line real-world US data demonstrated significantly longer median rwPFS (8 months) for patients treated with palbociclib + AI compared with patients who received AI alone13
† This data include patients with HR+ HER2- aBC who either received treatment with IBRANCE® plus AI or AI alone in the first-line setting. Median follow-up after sIPTW adjustment was 24.2 months (IQR, 14.2–34.9) in the IBRANCE® group and 23.3 months (IQR, 12.7–34.3) in those taking letrozole alone.
The safety profile of palbociclib is consistent between RCTs and RWE, with adverse events that can be effectively managed in real-world clinical practice11-13, 18, 19
The combination of data from both RCTs and RWE offers mutually complementary information.8
RWE can be used to gather data in patients excluded from or unable to be evaluated in RCTs.3,5,9
aBC : advanced breast cancer, ASCO : American Society of Clinical Oncology, EHR : Electronic Health Record, EMA : European Medicines Agency, FDA : Food and Drug Administration, HER2 : Human Epidermal growth factor Receptor 2, HR : Hormone Receptor, PRO : Patient-Reported Outcome, RCT : Randomised Controlled Trial, RWD : Real-World Data, RWE : Real-World Evidence, rwPFS : real-world Progression-Free Survival
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
Connect virtually with a Pfizer representative to discuss promotional information on a selected range of products.
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-PFE-GBR-2688. December 2020