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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
PALOMA pooled analysis: ARs based on pooled data set from 3 randomised studies (N = 872)1*PTs are listed according to MedDRA 17.1
†Infections includes all PTs that are part of the System Organ Class Infections and infestations.
‡Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
§Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
||Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased. ADR =  adverse drug reaction; AE = adverse event; AR = adverse reaction; ILD = interstitial lung disease; MedDRA = Medical Dictionary for Regulatory Activities; OS = overall survival; PALOMA = Palbociclib: ongoing trials in the management of breast cancer; PT = preferred terms.

Reference: 1. Ibrance EU Summary of Product Characteristics.
Adapted from Ibrance EU SmPC
PALOMA pooled analysis: Laboratory abnormalities* observed in pooled data set from 3 randomised studies (N = 872)1*Note: Laboratory results are graded according to the NCI CTCAE version 4.0 severity grade.
†Letrozole or fulvestrant.
AE = adverse event; ALT= alanine aminotransferase; AST = aspartate aminotransferase; NA = not applicable; NCI CTCAE = National Cancer Institute Common Toxicity Criteria for adverse events; OS = overall survival; 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; PFS = progression-free survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3; WBC = white blood cell.

Reference: 1. Ibrance EU Summary of Product Characteristics.
Adapted from Ibrance EU SmPC

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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i- The product information provided in this site is intended only for Healthcare Professionals of UAE. The products discussed herein may have different product labeling in different countries.

 

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

PP-UNP-BHR-0180