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EMBRACA Study
EMBRACA StudyEfficacy OutcomesSafetyPROs
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Support & ResourcesSupportVideosMaterialsTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsHematologic/Nonhematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptoms
Talzenna MoA

The content of this website has been produced in line with the Talzenna®▼ Summary of Product Characteristics for Great Britain and Northern Ireland. Talzenna® (talazoparib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

EMBRACA Study: Safety Profile and Tolerability

TALZENNA® has a generally manageable safety profile.1,2

The safety and tolerability of TALZENNA® in patients with gBRCA1/2-mutated HER2- LA/mBC have been evaluated in the Phase 3 EMBRACA study. Of the 431 patients in the intention-to-treat population who underwent randomisation, 286 patients receiving 1 mg once-daily TALZENNA® arm and 126 patients receiving physician’s choice chemotherapy† were available for safety profile analysis.1,3

Most frequent (≥20% in the TALZENNA arm) adverse events of any Grade observed in the EMBRACA study*3

 Adapted from Litton JK, et al. N Engl J Med. 2018. Supplementary appendix.† Physician’s choice of chemotherapy included capecitabine, eribulin, gemcitabine or vinorelbine.
* Graded according to NCI CTCAE 4.03.
‡ Includes anaemia and decreased haemoglobin level.
§ Includes neutropenia, decreased neutrophil count and neutropenic sepsis.
¶ Alopecia Grade 1: 23% with TALZENNA versus 20% with chemotherapy; Grade 2: 2% with TALZENNA versus 8% with chemotherapy. 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.
** Includes thrombocytopenia and decreased platelet count.Most adverse events associated with TALZENNA® were managed with standard supportive medical therapy or dose reduction/interruption1,4Dose reductions
  • Dose reductions due to any adverse event of any grade occurred in 52.1% of TALZENNA® patients (n=286) vs 49.1% of capecitabine patients (n=55)††5,6
  • Median time to first dose reduction due to any adverse event was:5
    • For TALZENNA (n=286), 19.3 weeks (95% Cl: 17.1-30.9 months)
    • For capecitabine (n=55), 9.3 weeks (95% Cl: 6.4 months-NR)††
Dose interruptions
Type of Adverse Reactions  Adverse Reactions Withhold TALZENNA Until Levels Resolve to  Resume TALZENNA
Hematologic Hemoglobin
<8 g/dL		 ≥9 g/dL Resume TALZENNA at a reduced dose
Platelet count <50,000/μL ≥75,000/μL
Neutrophil count <1,000/μL ≥1,500/μL
Nonhematologic Grade 3 or Grade 4 ≤ Grade 1 Consider resuming TALZENNA at a reduced dose or discontinue 
  • Dose interruptions due to any adverse event of any grade occurred in 60.1% of TALZENNA® patients (n=286) vs 32.7% of capecitabine patients (n=55)††5,6
Discontinuation rate due to adverse events
  • 5.9% of TALZENNA patients (n=286) vs. 8.7% of chemotherapy patients (n=144)1,4
††Capecitabine was the only oral chemotherapy included in the comparator arm for this safety evaluation. Please refer to the TALZENNA SmPC for full safety profile information and guidance on the management of treatment-related adverse events.AE: adverse event, BRCA: breast cancer susceptibility geneExplore more Safety & Tolerability

View the TALZENNA® Safety & Tolerability page

 Learn moreLoading Dosing

View the TALZENNA® Dosing page

 Learn moreLoadingReferences:Hurvitz SA, et al. Oncologist. 2019;24:1-12.TALZENNA® Summary of Product Characteristics for Great Britain click here. TALZENNA® Summary of Product Characteristics for Northern Ireland click here. Litton JK, et al. N Engl J Med. 2018;379(8):753-763. Supplementary Material. Litton JK, et al. N Engl J Med. 2018;379(8):753-763.Data on file. Pfizer Inc., New York, NY.Hurvitz SA, et al. Oncologist. 2019;24:1-27. Supplementary Material.
PP-TAL-GBR-0229. July 2024

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