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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 Support & Services Support & Resources Patient support program/tools Events Materials Videos
Ibrance®  US Prescribing Information  Click Here
The PALOMA-3 OS final analysis of IBRANCE + fulvestrant in first-line or later treatment demonstrated a numerical difference in favour of IBRANCE + fulvestrant versus placebo + fulvestrant that did not reach statistical significance1,2Adapted from Ibrance SmPC.2
Data cut-off date: 13 April 2018.
*Not statistically significant at the prespecified significance level of 0.0235 (one-sided).2
†1-sided P value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior ET per randomisation.2
CI = confidence interval; ET= endocrine treatment; FUL = fulvestrant; HR = hazard ratio; OS = overall survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3; PLA = placebo; RCT = randomised controlled trial;  SmPC = summary of product characteristics.

References: 1. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936. 2. Master Gulf Levant-LPD-(Ibrance)-Capsules - 75 mg, 100 mg & 125 mg based on USPI date of Revision: December 2022 for UAE.Difference in median OS (not statistically significant) was observed across most subgroups, with estimated OS HRs similar to the OS HR of the overall ITT population1
  • Randomisation in PALOMA-3 was stratified according to the presence/absence of visceral metastasis, menopausal status at study entry and sensitivity to prior ET1
  • This analysis is not intended to demonstrate efficacy in a particular subgroup and is further limited by small numbers of patients in some subpopulations
Adapted from Turner NC, et al. 2018.1
Data cut-off date: 13 April 2018.
CI = confidence interval; ER = oestrogen receptor; ET = endocrine therapy; FUL = fulvestrant; HR = hazard ratio; ITT = intention-to-treat; NE = not estimable; OS = overall survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3; PLA = placebo; PR = progesterone receptor.

Reference: 1. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936.

Prescribing Information: Master GULF LEVANT-LPD- (Ibrance)- Capsules- 75 mg, 100 mg &125 mg based on USPI Revision date: December 2022 – United Arab Emirates

PP-IBR-ARE-0144

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