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MOA MOA MOA EfficacyEfficacyPALOMA-2 Study designPatient Characteristics Primary endpoint Secondary end point PALOMA-3Study design Patient Characteristics Primary endpoint Secondary end point SurvivalFinal analysis Subgroup analysis Prespecified groups Updated Subgroup analysis Safety Safety PALOMA pooled analysis Adverse reactions  & Laboratory abnormalities PALOMA 2 Adverse Events PALOMA 3 Adverse Events IBRANCE consistent  safety profile Pooled analysis of patients aged ≥65 years in the PALOMA trials No evidence of cumulative or delayed toxicity with up to 50 months Patients with visceral diseases GI ,  Liver toxicities, and QTC Dosing Dosing Once daily dosing Dose Modification Real-World EvidenceReal-world EvidenceIBRANCE is the only CDK4/6 inhibitor with >5 years of real-world experience Real-world data provide additional information Favorable progression free rates IRIS Study In the real world, IBRANCE benefits GuidelinesGuidelinesNCCN Guidelines ESMO Guidelines

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Information on how to access Ibrance® (palbociclib) prescribing information and adverse event reporting can be found at the bottom of the page.
IBRANCE is the only CDK4/6 inhibitor with >5 years of real-world experience1  that complements its wealth of robust clinical data2-4

CDK = cyclin-dependent kinase; FDA = Food and Drug Administration; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive;mBC = metastatic breast cancer; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3.

References: 1. U.S. Food and Drug Administration Approved drugs. Palbociclib (Ibrance). U.S. Food and Drug Administration Web site. https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance. Accessed December 2024. 2. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 3. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 4. Ibrance Data on file. Prescribers. 5. Ibrance Data on file. Patients. 6. Ibrance Data on file. Countries.

Real-world data can complement data from adding to the body of evidence by providing additional information that may aid in clinical practice1,2RCT = randomised controlled trial.

References: 1. de Lusignan S, et al. J Innov Health Inform. 2015;22(3):368-373. 2. Khozin S, et al. J Natl Cancer Inst. 2017;109(11). 3. Singal AG, et al. Clin Transl Gastroenterol. 2014;5(1):e45.The first CDK4/6 inhibitor to demonstrate favourable effectiveness in response rates and progression-free rates in the real-world setting*1- The IRIS study was an observational retrospective chart review that evaluated the  demographics, clinical characteristics, treatment patterns and clinical outcomes in  patients with HR+/HER2- ABC/mBC treated with IBRANCE combinations in the real-world setting in the United States, Argentina and Germany.

 In 652 patients in the United States*1:
  • CBR was >90% for both: patients treated with IBRANCE + AI and IBRANCE + FUL. For the majority of patients, PR or SD was reported as best response by the physician†
  • 64.3% of patients treated with first-line IBRANCE + AI were progression free at 2 years
*Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.2,3

†Clinical response was based on physician assessment reported at any time and was not based on the RECIST criteria. In RCTs, RECIST criterion for a PR is a ≥30% reduction in tumour size. In IRIS, complete response was defined as one where ‘CR’ has been recorded at any time (no 24-week minimum); PR was defined as one where ‘PR’ has been recorded at any time (no 24-week minimum); CBR was calculated by adding the percentages of patients who achieved CR, PR and SD ≥24 weeks; SD ≥24 weeks was defined as patient remained on IBRANCE for a minimum of 24 weeks, without complete or PR, death, treatment switch or progression; SD <24 weeks was defined as SD recorded for initial response, with a subsequent progression recorded <24 weeks or treatment switch for reason other than progression <24 weeks or death without recorded progression <24 weeks; progressive disease was recorded for patients with initial response without a subsequent partial or CR recorded.1
ABC = advanced breast cancer; AI = aromatase inhibitor; CBR = clinical benefit response; CDK = cyclin-dependent kinase; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive; IRIS = the ibrance real world insights; mBC = metastatic breast cancer; PR = partial response; RCT = randomized control trial; RECIST= Response Evaluation Criteria in Solid Tumours; SD = stable disease.
 
References: 1. Taylor-Stokes G, et al. Breast. 2019;43:22-27. 2. Gerstein HC, et al. Lancet. 2019;393(10168):210-211. 3. Corrigan-Curay J, et al. JAMA. 2018;320(9):867-868.

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