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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 & ResourcesMaterialsVideosElevateElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
It is important to test early for gBRCA mutations to inform treatment planning1,2
  • Patients with BRCA-mutated HER2- LA/mBC received more chemotherapy-based combination regimens and experienced more adverse events than patients with BRCA wild-type3*
Many patients are at risk

A retrospective real-world analysis of patients with gBRCA-mutated HER2- LA/mBC showed:4†

37%

had no known family history of BRCA-related cancers

65%

had HR+/HER2- disease

55 y

mean age​​​​​​​

gBRCA testing remains low: only 1 of 4 HER2- LA/mBC patients received testing in the EU5‡Testing for gBRCA mutations in patients with mBC helps inform treatment planning1,2 TNBC HR+/HER2-

TALZENNA is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.6

Image is for illustrative purposes only.
BRCA=breast cancer susceptibility gene; ESMO=European Society for Medical Oncology; gBRCA=germline breast cancer susceptibility gene; HER2-=human epidermal growth factor receptor 2 negative; HR+=hormone receptor-positive; LA/mBC=locally advanced/metastatic breast cancer; mBC=metastatic breast cancer; NCCN=National Comprehensive Cancer Network; PARP=poly (ADP-ribose) polymerase; PFS=progression-free survival; TNBC=triple-negative breast cancer.According to a retrospective real-world analysis of BRCA1/2 testing (somatic and/or germline), treatment patterns, and outcomes among 6161 HER2-LA/mBC patients in Germany, France, Italy, Spain, the UK, and the US between 2015 and 2017.3According to a retrospective real-world analysis of patient demographics, treatment patterns, and safety outcomes among 512 patients with BRCA1/2-mutated HER2- LA/mBC in Germany, France, Italy, Spain, and the US between September 2019 and April 2020.4
According to a retrospective real-world analysis of gBRCA1/2 testing among 2624 HER2- LA/mBC patients in Germany, France, Italy, Spain, Israel, and the US between 2019 and 2020.5
Explore more EMSO GUIDELINES
References:Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.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.Niyazov A, Quek RGW, Lewis K, Kemp J, Rider A. BRCA status, treatment patterns, and outcomes in HER2-negative advanced breast cancer: a multi-country real-world study. Poster presented at: ESMO Breast Cancer Annual Congress; May 2-4, 2019; Berlin, Germany. Poster 161P.Mahtani R, Niyazov A, Lewis K, et al. Patient demographics, treatment patterns and hematologic toxicities among patients with HER2- advanced breast cancer (ABC) and BRCA1/2 mutation(s): a multi-country real-world study. Poster presented at: ESMO Breast Cancer Virtual Meeting; May 23-24, 2020. Poster 669.Mahtani R, Niyazov A, Lewis K, et al. Germline BRCA1/2 (gBRCA1/2) mutation testing patterns among oncologists treating HER2- advanced breast cancer (ABC): results from a multi-country real-world study. Poster presented at: ESMO Breast Cancer Virtual Annual Meeting; May 23-24, 2020. Poster 652.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 progression

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Mechanism of action

Targeted treatment leads to cancer cell death via PARP inhibition and trapping6

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TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

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