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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PALOMA-3 overall survival (secondary endpoint) 

The PALOMA-3 OS final analysis of Palbociclib Pfizer in combination with fulvestrant in 1st line or later demonstrated a numerical difference in favour of Palbociclib Pfizer in combination with fulvestrant vs placebo + fulvestrant that did not reach statistical significance1,2

The difference in median OS with Palbociclib Pfizer in combination with fulvestrant (not statistically significant)1 was similar to the improvement in mPFS previously seen with the addition of Palbociclib Pfizer to fulvestrant in PALOMA-31,3

PALOMA-3 OS Kaplan-Meier Curve1,2Adapted from Palbociclib Pfizer SmPC2 and Turner NC, et al. 2018.1
Data cut-off date: April 13, 2018. Not statistically significant at the prespecified significance level of 0.0235 (1-sided).2 1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomisation.2Explore More
PALOMA-2

See PALOMA-2 overall survival data

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CI = confidence interval; ET = endocrine therapy; FUL = fulvestrant; HR = hazard ratio; HR+/HER2- = hormone receptor-positive/human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; n = number of patients; OS = overall survival; PLA = placebo; SmPC = Summary of Product Characteristics.
References:Turner NC, et al. N Engl J Med. 2018;379(20): 1926-1936.Palbociclib Pfizer Summary of Product Characteristics.Cristofanilli M, et al. ASCO 2021; Oral presentation 1000.
PALOMA-3

A broad range of patients with HR+/HER2- mBC are eligible for Palbociclib Pfizer + letrozole combination therapy

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