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 Experience1-9
There is a growing body of RWE for IBRANCE® in the UK and globally to complement PALOMA-2 and PALOMA-3 RCT data and to help support prescribing decisions for appropriate patients with HR+/HER2- ABC. 2–12
Real-world IBRANCE® patient populations and subgroups (including patients with visceral disease) achieved outcomes that complement those demonstrated across the PALOMA RCTs2-12
In ROIS, 90% of the overall population achieved complete response, partial response or stable disease (2%, 40% and 48%, respectively).5 Time to best response in the overall population was 3.5 months.5 Patients treated first-line or with de novo disease have achieved better outcomes vs overall population5
IBRANCE® demonstrates survival benefits in the real-world setting:
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†4
The safety profile of IBRANCE® is consistent between RCTs and RWE, with adverse events that can be effectively managed in real-world clinical practice2–9,13
* Time frame >24 months where follow-up available. Survival rate defined as the 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). Of the 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%
† These data include patients with HR+/HER2− ABC who either received treatment with IBRANCE® plus AI or AI alone in the first-line setting. The 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
RWE are generated or obtained from real-world practice rather than a clinical trial setting.14,15
Therefore, the characteristics of real-world studies differ from those of RCTs.14,15
Observational retrospective analyses are not intended for direct comparison with clinical trials due to differences in study design and settings.
▼ 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.
ABC : Advanced Breast Cancer, AI : Aromatase Inhibitor, ET : Endocrine Therapy, HR+/HER2− : Hormone Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative, IRIS : IBRANCE® Real-World Insights, IQR : Interquartile Range, LHRH : Luteinising Hormone-Releasing Hormone, OS : Overall Survival, P-REALITY : Palbociclib REAl-world first-LIne comparaTive effectiveness studY, RCT : Randomised Controlled Trial, ROIS : Real Outcomes Ibrance Study, RWE : Real-World Evidence, rwPFS : Real-World Progression-Free Survival, sIPTW : Stabilised Inverse Probability of Treatment Weighting, SmPC : Summary of Product Characteristics
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PP-PFE-GBR-2688. December 2020