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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.
(1%, 0%) of patients experienced Grade ≥3  for diarrhoea, (2%) ALT increases and (3%, 4%) AST increases respectively in PALOMA-2 & PALOMA-3 trials 1PALOMA-2 GI & Liver Adverse Events

Example

PALOMA-3 GI & Liver Adverse Events

 *Stomatitis includes the following PTs: Aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain and stomatitis.
AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; GI = gastrointestinal; PALOMA = Palbociclib: ongoing trials in the management of breast cancer.

Reference: 1. Ibrance EU Summary of Product Characteristics. Revision Date: September 2023 for UAE, Bahrain, Kuwait, Oman & Qatar.No clinically relevant effects on the QTc interval were reported for IBRANCE1
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  • In a PALOMA-2 QTc evaluation substudy, no clinically relevant effects on the QTc interval were reported for IBRANCE*2
    • ​​​​​​​IBRANCE + letrozole at the recommended therapeutic dosing regimen did not prolong the QTc interval to a clinically relevant extent

 
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  • The current LPD for IBRANCE does not include provisions for ECG monitoring1:
    • Additional monitoring may be necessary based on the individual patient
  • IBRANCE does not have any special warnings or precautions for use with QTc-prolonging drugs in the current LPD1

 
   
*PALOMA-2 (IBRANCE + letrozole vs. placebo + letrozole in ET-sensitive HR+/HER2- mBC) included a QTc evaluation substudy as a definitive QT interval prolongation assessment for palbociclib.2 Time-matched triplicate ECGs were performed at 0, 2, 4, 6 and 8 hours at baseline (Day 0) and on Cycle 1 Day 14.2 Additional ECGs were collected from all patients for safety monitoring.2 The QT interval was corrected for heart rate using QTcF, QTcB and a study-specific correction factor (QTcS). No patient in the IBRANCE + letrozole arm of the substudy had a maximum post-baseline QTcS or QTcF value of ≥480 ms, or a maximum increase from clock time–matched baseline for QTcS or QTcF values of ≥60 ms.2 The upper bounds of the one-sided 95% CI for the mean change from time-matched baseline for QTcS, QTcF and QTcB at all time points and at steady-state Cmax following repeated administration of 125 mg IBRANCE were less than 10 ms.2 There was no evidence of clinically significant effects of IBRANCE + letrozole on QTc, the PR interval or the QRS complex.2

Cmax= maximum concentration; ECG = electrocardiogram; ET = endocrine therapy; HER2- = human epidermal growth factor receptor 2-negative; HR+ = hormone receptor-positive; LPD: local product document; mBC = metastatic breast cancer; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; QTc = QT interval corrected for heart rate; QTcB = QT interval Bazett’s correction; QTcF = QT interval Fridericia’s correction; QTcS = QT interval study-specific correction factor.


Reference:
1. Ibrance® (palbociclib) Local Product Document. Revision Date: September 2023 for UAE, Bahrain, Kuwait, Oman & Qatar.
2. Durairaj C, et al. Anticancer Drugs. 2018;29(3):271-280.

Prescribing Information:

Bahrain Prescribing Information
Kuwait Prescribing Information
Oman Prescribing Information
Qatar Prescribing Information
UAE Prescribing Information

PP-IBR-QAT-0027

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