TALZENNA®▼ (talazoparib)| Efficacy and safety | Haematologic/non haematologic adverse events| PfizerPro Ireland

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

Log out

Our medicines

Therapy areas

Explore content

Materials

Videos

Podcasts

Let’s connect

Let's connect

About

TALZENNA MoA

Talzenna MoA

gBRCA testing

Identifying patients

Guidelines

Study design

Baseline characteristics

Efficacy & Safety

TALZENNA efficacy

Primary endpoint & subgroup analysis

Secondary endpoints: ORR

Secondary endpoint: OS

Exploratory endpoints: DoR & TTR

TALZENNA safety

Safety and tolerabillity

Adverse events

Haematologic/Nonhaematologic AEs

Patient-reported outcomes with TALZENNA

Patient-reported outcomes

GHS/QoL

Breast symptoms

Dosing

Dose recommendation and special populations

Dose modifications/management

Patient Profiles

Support & Resources

Materials

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/reduction^1,2

Nonhaematologic adverse events from exploratory analysis

Majority of nonhaematologic adverse events were Grade 1 in severity^4§||

Most alopecia was hair thinning, not hair loss^3,5

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.

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 Characteristics

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 Account

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

Account

Log 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.

PP-UNP-IRL-0176. January 2023

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.