Palbociclib Pfizer

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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Effect of Palbociclib Pfizer on QTc interval PALOMA-2 QTc evaluation

In a PALOMA-2 QTc evaluation sub-study, no clinically relevant effects on the QTc interval were reported for Palbociclib Pfizer:*2

  • Palbociclib Pfizer in combination with letrozole at the recommended therapeutic dosing regimen did not prolong the QTc interval to a clinically relevant extent
 ECG not included 

The current SmPC for Palbociclib Pfizer does not include provisions for ECG monitoring:1

  • Additional monitoring may be necessary based on the individual patient 
  • Palbociclib Pfizer does not have any special warnings or precautions for use with QTc-prolonging drugs in the current SmPC1
PALOMA-2 (Palbociclib Pfizer + letrozole vs placebo + letrozole in ET sensitive HR+/HER2- mBC) included a QTc evaluation sub-study as a definitive QT interval prolongation assessment for palbociclib.2 
Time-matched triplicate ECGs were performed at 0, 2, 4, 6, and 8 h 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 Fridericia’s correction (QTcF), Bazett’s correction (QTcB), and a study-specific correction factor (QTcS). No patients in the Palbociclib Pfizer + letrozole arm of the sub-study 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% confidence interval 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 Palbociclib Pfizer were less than 10 ms.2
There was no evidence of clinically significant effects of Palbociclib Pfizer + letrozole on QTc, the PR interval, or the QRS complex.2
Explore More PALOMA-2 AEs See AE tables PALOMA-3 AEs See AE tables
AE = adverse event; ECG = electrocardiogram; ET = endocrine therapy; HR+/ HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic 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; SmPC = Summary of Product Characteristics.References:Palbociclib Pfizer Summary of Product Characteristics.Durairaj C, et al. Anticancer Drugs. 2018;29(3):271-280.
Selected safety features

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