This site is intended only for healthcare professionals resident in the United Kingdom

Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

See all Therapy areas

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.

Real World Evidence

Confidence Through Experience11-19

More Than 4 Years of Real World Experience

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 Outcomes complement those in PALOMA

Real-world palbociclib patient populations and subgroups (including patients with visceral disease) achieved outcomes that complement those demonstrated across the PALOMA RCTs11-17

Real World Survival Rates

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%.​​​​​​​

Robust Real World Efficacy

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.

Established and Well Tolerated Safety Profile

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

What is the difference between RCT and RWE?

What is the value of real-world experience?

The combination of data from both RCTs and RWE offers mutually complementary information.8

​​Why is real-world experience important?

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.

References
  1. Seyfert-Margolis V. Nat Biotechnol. 2018;36(3):228-232.
  2. Maissenhaelter BE, et al. Onkologie (Berl). 2018;24(Suppl 2):91-98.
  3. Beaulieu-Jones BK, et al. Review Clin Pharmacol Ther. 2020;107(4):843-852.
  4. U.S FDA approves Ibrance® (palbociclib) for the treatment of men with HR+, HER2- metastatic breast cancer. Available at:https://www.pfizer.com/news/press-release/press-release detail/u_s_fda_approves_ibrance_palbociclib_for_the_treatment_of_men_with_hr_her2_metastatic_breast_cancer (accessed May 2021)
  5. Blonde L, et al.  Adv Ther. 2018;35:1763-1774.
  6. Visvanathan K, et al. J Clin Oncol. 2017;35(16):1845-1854.
  7. ASCO CancerLinQ. Available at: https://www.cancerlinq.org/ (accessed May 2021)
  8. Kim HS, et al. J Korean Med Sci. 2018;33(34):e213.
  9. Webster J, Smith D. Clin Ther. 2019;41:336-349.
  10. Zuidgeest MGP, et al. J Clin Epidemiol. 2017;88:7-1.
  11. Pfizer. Data on file. IBRANCE Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020
  12. Taylor-Stokes G, et al. Poster 269P. Presented at European Society for Medical Oncology Virtual Congress, 19–21 September 2020
  13. DeMichele A, et al. Breast Cancer Res 2021;23:37–47.
  14. Finn RS et al. N Engl J Med 2016;375:1925-1936.
  15. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.
  16. Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729.
  17. Turner NC, et al. N Engl J Med 2018;379:1926-1936.
  18. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  19. Ettl J, et al. Breast Cancer Res 2020;22:27.
PP-IBR-GBR-3752. July 2021

Real World Evidence

Real-world patient data for IBRANCE® in advanced Breast Cancer
  • P-REALITY
  • IRIS (UK) Study

Indication

  • 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

Ask Pfizer

Connect virtually with a Pfizer representative to discuss promotional information on a selected range of products.

Book now

For UK Healthcare Professionals*

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

Yes

No