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

Established safety profile


​​​​​​​
Overview Adverse events in PALOMA-2 Adverse events in PALOMA-3

​​​​​​​AEs 
(≥10%) from any cause reported in PALOMA-2 (as-treated population)2
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​​​​​​​Adapted from Finn RS, et al. 2016.2


​​​​​​​Grading according to CTCAE 4.0. Data cut-off date: February 26, 2016.
*Categorised according to the MedDRA preferred terms.Febrile neutropenia was reported in 1.8% of patients in the IBRANCE + letrozole group and in no patients in the placebo + letrozole group.2 ‡In the IBRANCE + letrozole group, 30.2% of patients had Grade 1 alopecia and 2.7% had Grade 2. In the placebo + letrozole group, 14.9% of patients had Grade 1 alopecia and 0.9% had Grade 2.2


AE = adverse eventCTCAE = Common Terminology Criteria for Adverse EventsLET = letrozole​​​​​​​;  MedDRA = Medical Dictionary for Regulatory Activity; n = number of patientsPLA = placebo.
​​​​​​​

References

  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.

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All rights reserved. Date of preparation: June 2020 PP-IBR-GLB-0254

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