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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
IBRANCE in combination with fulvestrant in first-line or later treatment doubled mPFS versus placebo + fulvestrant in patients with progression on/after ET in the PALOMA-3 trial*1,2In a 2:1 randomised, double-blind, Phase III trial of women with HR+/HER2- mBC whose disease progressed following ET (N = 521)1
Adapted from Cristofanilli M, et al. 20161; Ibrance SmPC.2
*Evaluated according to RECIST Version 1.1.1
†Data cut-off date: 16 March 2015.
‡Updated non-prespecified analysis. Data cut-off date: 23 October 2015.
CI = confidence interval; ET = endocrine therapy; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative; HR+= hormone receptor-positive; HR = hazard ratio; mBC = metastatic breast cancer; mPFS = median progression-free survival; PALOMA-3: the Palbociclib ongoing trials in the management of breast cancer 3 PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumours; SmPC = summary of product characteristics.

References: 1. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 2. Master Gulf Levant-LPD-(Ibrance)-Capsules - 75 mg, 100 mg & 125 mg based on USPI date of Revision: December 2022 for UAE.Improved tumour response with IBRANCE + fulvestrant versus placebo + fulvestrant in first-line or later treatment (secondary end point)1Adapted from Ibrance [Local Product Document] Revision December 2022.1
Data cut-off date: 23 October 2015.
*Defined as confirmed CR or PR.2
†Defined as confirmed CR or PR or SD for ≥24 weeks.2
CBR = clinical benefit rate; CR= complete response FUL = fulvestrant; ITT = intention-to-treat; ORR = objective response rate; PR= partial response; PLA = placebo; SR= stable disease.
References: 1. Master Gulf Levant-LPD-(Ibrance)-Capsules - 75 mg, 100 mg & 125 mg based on USPI date of Revision: December 2022 for UAE. 2. Turner NC, et al. Ann Oncol. 2018;29(3):669-680.

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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ii- The information provided on this website is intended only for healthcare professionals of UAE.
 

PP-UNP-BHR-0180