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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.
First-in-class IBRANCE delivers dual inhibition with endocrine therapy by selectively inhibiting CDK4/6 downstream of ERBoth CDK4 and CDK6 are key regulators of cell division1,2

- Inhibition of CDK4/6 helps control cell growth by inducing G1 arrest and reducing cell-cycle progression
- It is important to inhibit both CDK4 and CDK6 for effective suppression of tumor activity

CDK4/6 is also active in healthy cells3

- Inhibiting CDK4/6 in healthy cells can result in side effects, some of which may be serious
- Human bone marrow mononuclear cells treated with palbociclib in the presence or absence of an antiestrogen in vitro did not become senescent and resumed proliferation following palbociclib withdrawal. This evidence suggests IBRANCE may not have cytotoxic effects on bone marrow cells
CDK4/6=cyclin-dependent kinases 4 and 6; ER=estrogen receptor.References:Fry DW, Harvey PJ, Keller PR, et al. Specific inhibition of cyclin-dependent kinase 4/6 by PD 0332991 and associated antitumor activity in human tumor xenografts. Mol Cancer Ther. 2004;3(11):1427-1438.Chen P, Lee NV, Hu W, et al. Spectrum and degree of CDK drug interactions predicts clinical performance. Mol Cancer Ther. 2016;15(10):2273-2281. Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35.

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PP-IBR-QAT-0027

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