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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.
In an exploratory, long-term pooled analysis, there was no evidence of cumulative or delayed toxicity with up to 50 months of treatment with IBRANCE + letrozole or IBRANCE + fulvestrant in first-line or later treatment1Safety profile remained consistent and manageable with additional follow-up from the Phase III PALOMA-2 and PALOMA-3 trials.2,3Adapted from Diéras V, et al. 2019.1
Data cut-off dates: 2 January 2015 for PALOMA-1, 26 February 2016 for PALOMA-2 and 23 October 2015 for PALOMA-3.1
*Cluster terms were used and are defined in the supplementary materials.
PALOMA-1 = Palbociclib: ongoing trials in the management of breast cancer; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3.

References: 1. Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430. 2. Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729. 3. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936.In an analysis of PALOMA-2 and PALOMA-3, IBRANCE + letrozole and IBRANCE + fulvestrant in first-line or later treatment demonstrated a consistent safety profile in patients with visceral disease1Data cut-off dates: 23 October 2015 for PALOMA-3 and 26 February 2016 for PALOMA-2.
*AEs reported using a cluster of PTs as follows: Anaemia is any event having a PT that equals to anaemia or haematocrit decreased or haemoglobin decreased; infections is any event having a PTs that is part of the System Organ Class Infections and infestations; infections is any event having a PT that is part of the System Organ Class Infections and infestations; leukopenia is any event having a PT that equals to leukopenia or white blood cell count decreased; neutropenia is any event having a PT that equals to neutropenia or neutrophil count decreased.
PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3; TEAE = treatment-emergent adverse event.

References: 1. Turner NC, et al. Ann Oncol. 2018;29(3):669-680. 2. Turner NC, et al. Ann Oncol. 2018;29(3):669-680. Supplementary Appendix.

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