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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 eventsHaematologic/Nonhaematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesSupport & ResourcesSupport & ResourcesMaterials
Significant overa​​​​​​​ll improvement in GHS/QoL vs chemotherapy1*†​​​​​​​Estimated overall mean change from baseline in GHS/QoL: Prespecified exploratory:‡ 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 GHS/QoL vs chemotherapy1ll Time to definitive clinically meaningful deterioration of GHS/QoL: 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

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 decrease and no subsequent observations with a <10-point decrease from baseline. Results analyzed with the use of a stratified log-rank test, summarized with the use of Kaplan-Meier methods. Explore more Breast symptoms
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. 
​​​​​​​▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0061 April 2023
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

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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