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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

Real World Evidence

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

IBRANCE® has >6 years of cumulative real-world experience, and there is a growing body of RWE in the UK and globally to support the use of IBRANCE2-5,10,11

​​​​​​​Key IBRANCE® RWE studies are the ROISIRIS (UK) Study and the P-REALITY3-5,12​​​​​​​​​​

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 the IRIS (UK) Study, 9 out of 10 patients were alive at 2 years (weighted with median patient numbers*)​​​​​​​​​​​​​​​​​​​​​

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

​​​​​​​The Value of RWE

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.

​​​​​​​Why is RWE important?

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 studYRCT : 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

  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Taylor-Stokes G, et al. Breast 2019;43:22–27.
  3. Pfizer Ltd. Data on file. IBRANCE® Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020.
  4. DeMichele A, et al. Breast Cancer Res 2021;23:37–47.
  5. Palmieri C, et al. Poster #1710. Presented at the ESMO Congress 2021.
  6. Finn RS, et al. N Engl J Med 2016;375:1925–1936.
  7. Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729.
  8. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.
  9. Turner NC, et al. N Engl J Med 2018;379:1926–1936.
  10. Waller J, et al. J Glob Oncol 2019;5:JGO1800239.
  11. Mycock K, et al. Poster P510. Presented at the EBCC Virtual Congress, 2–3 October 2020.
  12. Taylor-Stokes G, et al. Poster 269P. Presented at ESMO Virtual Congress, 19–21 September 2020.
  13. Ettl J, et al. Breast Cancer Res 2020;22:27.
  14. Khozin S, et al. J Natl Cancer Inst 2017;109: doi: 10.1093/jnci/djx187.
  15. Singal AG, et al. Clin Transl Gastroenterol 2014:5.e45.
  16. Beaulieu-Jones, et al. Clin Pharmacol Ther 2020;107:843–852.
  17. Webster J and Douglas Smith B, Clin Ther 2019;41:336–349.
  18. Maissenhaelter BE, et al. Onkologie (Berl) 2018;23:91–98.
  19. Nordon C, et al. Value Health 2016;9:75–81.
  20. Mann CJ. Emerg Med J 2003;20:54–60.
  21. Portela MC, et al. Postgrad Med J 2015;91:343–354.
  22. Berger M, et al. Value Health 2017;20:1003–1008.
PP-IBR-GBR-4081. February 2022

Real World Evidence

Real-world patient data for IBRANCE® in advanced breast cancer
  • ROIS
  • IRIS (UK) Study

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

    ​​​​​​​PALOMA-3 Trial


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  • IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
       - In combination with an aromatase inhibitor; or
    ​​​​​​​   - In combination with fulvestrant in women who have received prior ET

    In pre- or perimenopausal women, the ET should be combined with a LHRH agonist

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PP-PFE-GBR-3863. November 2021



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