Ibrance is indicated for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy.1

Real-world Experience

What is RWD and RWE IBRANCE RWE Initiatives Flatiron IRIS
Technology-enabled real-world evidence (RWE) can now complement clinical trials to provide the full picture of patient outcomes2
RCT
RWE
ASCO = American Society of Clinical Oncology; FDA = Food and Drug Administration; RCT = randomised controlled trial; RWD = real-world data; RWE = real-world evidence.
​​​​​​​
RWE is based on data from patients under real-world conditions, offering a patient-centred approach2
EHR = electronic health record; EMA = European Medicines Agency; FDA = Food and Drug Administration; RWD = real-world data; RWE  = real-world evidence.

The combination of data from both RCTs and RWE offers mutually complementary information2

RCT = randomised controlled trial; RWE = real-world evidence.
​​​​​​​
RWE can be used to gather data in patients excluded from or unable to be evaluated in RCTs4,6,11
RWE studies can: 
RCT = randomised controlled trial; RWE = real-world evidence.

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References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 10, 2021.
  2. Seyfert-MargolisV. Nat Biotechnol. 2018;36(3):228-232.
  3. MaissenhaelterBE, et al. Onkologie(Berl). 2018;24(Suppl2):91-98.
  4. Beaulieu-Jones BK, et al. Review ClinPharmacolTher. 2020;107(4):843-852
  5. 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
  6. Blonde L, et al.  AdvTher. 2018;35:1763-1774.
  7. VisvanathanK, et al. J ClinOncol. 2017;35(16):1845-1854.
  8. ASCO CancerLinQ. Available at: https://www.cancerlinq.org/. Accessed May 2020.
  9. US Food and Drug Administration. Real-world evidence. Available at: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Accessed May 2020.
  10. Cave A, et al. ClinPharmacolTher. 2019;106:36-39.
  11. Webster J, Smith D. ClinTher. 2019;41:336-349.
  12. Kim HS, et al. J Korean Med Sci. 2018;33(34):e213.
  13. Zuidgeest MGP, et al. J ClinEpidemiol. 2017;88:7-13.

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