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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
In the prespecified subgroup of patients with documented sensitivity to previous ET,* the absolute numerical difference in mOS was 10.0 monthsmOS: 39.7 months with IBRANCE + fulvestrant (95% CI: 34.8-45.7) versus 29.7 months with placebo + fulvestrant (95% CI: 0.55-0.94), HR=0.72.1Adapted 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.
The difference in mOS with IBRANCE + fulvestrant in first-line or later treatment (not statistically significant) was similar to the improvement in mPFS previously seen with the addition of IBRANCE to fulvestrant in PALOMA-31Adapted from Turner NC, et al. 2018.1
*Data cut-off date: 23 October 2015.
Data cut-off date: 13 April 2018.
CI = confidence interval; FUL = fulvestrant; HR = hazard ratio; mOS = median overall survival; mPFS = median progression-free survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3; PLA = placebo; RCT = randomised controlled trial.

Reference: 1. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936.
IBRANCE has included a broad range of patients with HR+/HER2- mBC in its clinical trials1,2
**Pre-/perimenopausal patients enrolled in PALOMA-3 received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.2
†In PALOMA-2, 40.1% of IBRANCE-treated patients had a DFI of >12 months and 22.3% had a DFI of ≤12 months (defined as time from adjuvant or neoadjuvant therapy to recurrence).1 Patients who received a non-steroidal AI (i.e. anastrozole or letrozole) as a component of their prior adjuvant or neoadjuvant therapy were excluded from the study if they had disease progression while receiving the therapy or within 12 months after completing the therapy.1,3
Patients were defined as sensitive to prior ET if they had a relapse after 24 months of adjuvant ET or had a clinical benefit (OR [complete or partial] or SD lasting ≥24 weeks) from prior ET in the context of advanced disease.4
§Those who are not ET sensitive.
||Newly metastatic disease applies to patients who had not received any prior systemic therapy, for whom a determination of DFI was not possible.1
Patients with known active uncontrolled or symptomatic CNS metastases were excluded.1,2
AI = aromatase inhibitor; CNS = central nervous system; DFI = disease-free interval; ET = endocrine therapy; FUL = fulvestrant; HER2- = human epidermal growth factor receptor 2-negative; HR+= hormone receptor-positive; LET = letrozole; LHRH = luteinising hormone-releasing hormone; mBC = metastatic breast cancer; OR = overall response; 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; PLA = placebo.; SD= stable disease.

References: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 3. Ibrance EPAR Public assessment report. 25 November 2016. EMA Web site: Accessed August 2023. 4. 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


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