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 & ResourcesMaterialsVideosElevateElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
Haematologic adverse events from exploratory analysis

Most common adverse events with TALZENNA were haematologic; they occurred within the first 3 to 4 months and were transient1

  • With appropriate management, median duration of Grades 3-4* anaemia, neutropenia, and thrombocytopenia was ≤8 days

<2% of patients discontinued TALZENNA due to haematologic adverse events1

Managed with supportive medical therapy, including packed red blood cell transfusion (38.1%) or iron preparation (16.6%), or dose interruption/reduction1,2

Nonhaematologic adverse events from exploratory analysis

Majority of nonhaematologic adverse events were Grade 1 in severity4§||

  • Most alopecia was hair thinning, not hair loss3,5
AE=adverse event; CTCAE=Common Terminology Criteria for Adverse Events; ITT= intent to treat; NCl=National Cancer Institute; PFS=progression-free survival; PRO=patient-reported outcome.Graded according to NCI CTCAE 4.03.Post hoc exploratory analysis. The analysis data cutoff date was September 15, 2017, and was conducted in the PRO-evaluable population. 
The analysis data cutoff date was September 15, 2017, and was conducted in the safety population.
Prespecified exploratory analysis. The analysis data cutoff date was September 15, 2017, and was conducted in the PRO-evaluable population. PRO-evaluable patients were defined as those in the ITT population with baseline assessment and ≥1 post-baseline assessment before the end of study treatment.6
Grade 1 defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection. A different hairstyle may be required to cover the hair loss, but it does not require a wig or hairpiece to camouflage. Grade 2 defined as hair loss of ≥50% of normal for that individual that is readily apparent to others. A wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact.
Explore more PROs
References:Hurvitz SA, Gonҫalves A, Rugo HS, et al. Talazoparib in patients with a germline BRCA-mutated advanced breast cancer: detailed safety analyses from the phase III EMBRACA trial. Oncologist. 2019;24:1-12.Hurvitz SA, Gonҫalves A, Rugo HS, et al. Talazoparib in patients with a germline BRCA-mutated advanced breast cancer: detailed safety analyses from the phase III EMBRACA trial (supplement). Oncologist. 2019;24:1-27.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.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.National Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: National Institutes of Health. Revised June 2010, version 4.03. NIH publication 09-5410.Ettl J, Quek RGW, Lee KH, et al. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018;29:1939-1947.
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
TALZENNA safety Significantly longer PFS

Superior to chemotherapy in delaying disease progression7​​​​​​​

See the data 
Convenient, once-daily oral dosing

One dose once a day with or without food7

Learn 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

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 © 2024 Pfizer Limited. All rights reserved.
 

PP-UNP-IRL-0733. March 2024
For Healthcare Professionals in the Republic of Ireland *

The information on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland and contains promotional content.

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

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

*The IPHA Code definition of a healthcare profressional is a person of any of the following classes: (i) Registered medical practitioners (ii) Registered dentists (iii) Registered pharmacists (iv) Registered nurses

Terms of use

PP-UNP-IRL-0733 . March 2024

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.

PP-UNP-IRL-0733. March 2024