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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
Most adverse events in the EMBRACA study were managed with standard supportive medical therapy or dose interruption/reduction1,2

Median time to first dose reduction due to any adverse event was
~5 months (19.3 weeks [95% Cl: 17.1-30.9]) with TALZENNA vs
~2 months (9.3 weeks [95% Cl: 6.4-NR]) with chemotherapy3,4*

  • Dose interruptions due to any adverse event of any grade occurred in 60% of TALZENNA patients vs 33% of chemotherapy patients3,4
  • Dose reductions due to any cause occurred in 52% of TALZENNA patients vs 49% of chemotherapy patients3,4
  • The most common adverse event with TALZENNA was anaemia5
  • 0.7% of patients discontinued TALZENNA due to anaemia overall2
  • Most Grade 3-4 toxic effects associated with the use of TALZENNA were haematologic laboratory abnormalities, were not associated with substantial clinical sequelae, and did not result in drug discontinuation1
Discontinuation rate due to adverse events1Adapted from Litton et al. N Engl J Med. 2018.1Discontinuation rate from pooled analysis6

The pooled analysis included 494 patients who received talazoparib at 1 mg daily in clinical studies for solid tumours, including 286 patients from a randomised Phase 3 study with germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer and 83 patients from a nonrandomised Phase 2 study in patients with germline BRCA-mutated locally advanced or metastatic breast cancer.

Adapted from TALZENNA SmPC.AE=adverse event; CI=confidence interval; NR=not reported; PFS=progression-free survival.Capecitabine was the only oral chemotherapy included in the comparator arm. Explore more Haematologic/Non-haematologic
References: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.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.Data on file. Pfizer Inc., New York, NY.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. 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 progression6

 See the data  Convenient, once-daily oral dosing

One dose once a day with or without food6​​​​​​​

 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

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