This site is intended only for healthcare professionals resident in the Republic of Ireland

Search

Menu

Close

Sign in or RegisterLog out
Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up

Menu

Close

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
More than doubled ORR vs chemotherapy1*†‡​​​​​​​Adapted from TALZENNA SmPC, and Litton et al. N Engl J Med. 2018.2ORR according to line of therapy3†‡||Adapted from Ettl et al. ASCO 2019.339% of patients in the EMBRACA study received TALZENNA with no prior chemotherapy1ORR in gBRCA-mutated LA/mBC patients with TNBC or HR+/HER2- disease4,5†‡||Adapted from Eiermann et al. ASCO 2018,4 and Rugo et al. JNCI Cancer Spectr. 2020.5​​​​​
Cl=confidence interval; DoR=duration of response; gBRCA=germline breast cancer susceptibility gene; GHS=global health status; HER2-=human epidermal growth factor receptor 2 negative; HR+=hormone receptor-positive; LA/mBC=locally advanced/metastatic breast cancer; OR=odds ratio; ORR=objective response rate; OS=overall survival; QoL=quality of life; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer; TTR=time to response.Capecitabine, eribulin, gemcitabine, or vinorelbine. Conducted in the intent-to-treat population with measurable disease at baseline. Per RECIST v1.1, confirmation of response was not required.ORR is the proportion of patients who have a partial or complete response to treatment. Unconfirmed ORR includes patients with confirmed and unconfirmed responses.Depicts subgroup analyses from the overall EMBRACA study population. Small patient numbers can be a limitation of subgroup analyses.These findings should be interpreted with some caution due to the lower numbers of patients in the heavily pretreated (≥2 prior lines of chemotherapy) group. Explore more Overall survival
References:TALZENNA Summary of Product Characteristics. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.Ettl J, Hurvitz SA, Rugo HS, et al. Outcomes of talazoparib vs physician's choice of chemotherapy in patients with advanced breast cancer and a germline BRCA mutation by line of chemotherapy in the EMBRACA trial. Poster presented at: Annual Meeting of the American Society of Clinical Oncology; May 31-June 4, 2019; Chicago, IL. Poster 1071.Eiermann W, Rugo HS, Diab S, et al. Analysis of germline BRCA1/2 mutated (gBRCAm) hormone receptor–positive (HR+) and triple-negative breast cancer (TNBC) treated with talazoparib (TALA). Poster presented at: Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Poster 1070.Rugo HS, Ettl J, Hurvitz SA, et al. Outcomes in clinically relevant patient subgroups from the EMBRACA study: talazoparib vs physician's choice standard-of-care chemotherapy. JNCI Cancer Spectr. 2020;4(1):1-12.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. 
​​​​​​​ 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-0071 September 2023
TALZENNA efficacy Improved patient-reported outcomes

Significant improvements in GHS/QoL and breast symptoms6​​​​​​​

See the results 
Appropriate patients for TALZENNA

Meets the needs of patients with gBRCA-mutated HR+/HER2- or triple-negative LA/mBC1​​​​​​​

ccc

View patient profiles
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

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit https://www.medicines.ie

 

This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.

 

Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to Pfizer.ie, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.