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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
ESMO Guidelines recommend early gBRCA testing and talazoparib among preferred treatment options1According to ESMO Guidelines:Test
  • In the ABC setting, results from germline genetic testing have therapeutic implications and should be performed as early as possible
  • Appropriate counseling should be provided to patients and their families
Talazoparib is "associated with a PFS benefit, improvement in QoL and a favorable toxicity profile."Treat

Talazoparib is a preferred treatment option for patients with triple-negative ABC and a gBRCA mutation

Talazoparib is a recommended treatment option for patients with ER-positive ABC and a gBRCA mutation

The optimal sequence between a PARPi and ET with or without a CDK4/6 inhibitor is unknown. Given the OS benefit seen with CDK4/6 inhibitors, the panel recommends their use before a PARPi

ESMO Magnitude of Clinical Benefit Score: 4Category I/A: Evidence from at least one large randomized, controlled trial of good methodological quality (low potential for bias) or meta-analyses of well-conducted randomized trials without heterogeneity. Strong evidence for efficacy with a substantial clinical benefit, strongly recommended. 

Category I/B: Evidence from at least one large randomized, controlled trial of good methodological quality (low potential for bias) or meta-analyses of well-conducted randomized trials without heterogeneity. Strong or moderate evidence for efficacy but with a limited clinical benefit, generally recommended.
ABC=advanced breast cancer; BRCA=breast cancer susceptibility gene; CDK4/6=cyclin-dependent kinase 4/6; ER=estrogen receptor; ESMO=European Society for Medical Oncology; ET=endocrine therapy; gBRCA=germline breast cancer susceptibility gene; HER2-=human epidermal growth factor receptor 2 negative; mBC=metastatic breast cancer; OS=overall survival; PARP=poly (ADP-ribose) polymerase; PARPi=poly (ADP-ribose) polymerase inhibitor; PFS=progression-free survival; QoL=quality of life. Explore more EMBRACA study design
References:Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 5). Ann Oncol. 2020;31(12):1623-1649.  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-0059 April 2023
gBRCA testing Significantly longer PFS 

Superior to chemotherapy in delaying disease progression4 

 See the data  Mechanism of action

Targeted treatment leads to cancer cell death via PARP inhibition and trapping4

 Explore more
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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