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AboutTALZENNA MoATalzenna MoAgBRCA testingIdentifying patientsGuidelinesStudy designStudy designBaseline characteristicsEfficacy & SafetyTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesPrescribing InformationSupport & ResourcesSupport & ResourcesMaterialsElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
Significantly improved breast symptoms vs chemotherapy1*†​​​​​​​

TALZENNA® was associated with significant improvement from baseline† in patient-reported breast symptoms and delayed time to definitive clinically meaningful deterioration‡§ vs. chemotherapy.​​​​​​

 Estimated overall mean change from baseline in breast symptoms: Prespecified exploratory endpoint‡ Adapted from Litton et al. Ann Oncol. 2020.1​​​​​​​

PROs were included as exploratory endpoints in this open-label study; analyses were prespecified and adjustments for multiplicity were not made. No efficacy conclusions can be made from these data.2​​​​​​​

Significantly delayed time to definitive clinically meaningful deterioration§ in patient-reported breast symptoms vs chemotherapy1ll Time to definitive clinically meaningful deterioration in breast symptoms: Prespecified exploratory endpoint (medians not reached) Adapted from Litton et al. Ann Oncol. 2020.1

PROs were included as exploratory endpoints in this open-label study; analyses were prespecified and adjustments for multiplicity were not made. No efficacy conclusions can be made from these data.2

AE=adverse event; Cl=confidence interval; GHS=global health status; ITT=intent-to-treat; PFS=progression-free survival; PROs=patient-reported outcomes; QoL=quality of life.Conducted in the PRO-evaluable population, defined as those in the ITT population with a baseline assessment and at least 1 post-baseline assessment. Capecitabine, eribulin, gemcitabine, or vinorelbine. Results from longitudinal repeated measures analyses (mixed-effects model). Defined as the time from randomization to the first observation with a ≥10-point increase and no subsequent observations with a <10-point increase from baseline. Results analyzed with the use of a stratified log-rank test, summarized with the use of Kaplan-Meier methods. Explore more Dosing
References:Litton JK, Hurvitz SA, Mina LA, et al. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020;31(11):1526-1535.Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation (supplementary appendix). N Engl J Med. 2018;379(8):753-763.Data on file. Pfizer Inc., New York, NY.TALZENNA® Summary of Product Characteristics. 

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0107 May 2024
Patient-reported outcomes with TALZENNA® Significantly longer PFS

Superior to chemotherapy in delaying disease progression4

 See the data  Manageable safety profile 

AEs were manageable with a low discontinuation rate4

 Review safety
TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

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PP-UNP-IRL-0891. February 2025
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PP-UNP-IRL-0891. February 2025