# Talazoparib

Source: https://onco.cc/drugs/talazoparib/  
OnCo record `talazoparib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Talazoparib is a PARP inhibitor that traps PARP on DNA about 100 times more strongly than olaparib, which is why it works at a 1 mg daily dose. It is approved for germline BRCA-mutant HER2-negative breast cancer and, with enzalutamide, for HRR-mutant castration-resistant prostate cancer; anaemia is its dominant side effect.

## Summary

Talazoparib is a PARP inhibitor with about 100 times greater PARP trapping potency than olaparib, which lets it work at a 1 mg daily dose. It was approved in 2018 for germline BRCA-mutant HER2-negative locally advanced or metastatic breast cancer on EMBRACA, and in 2023 with enzalutamide for HRR-mutant metastatic castration-resistant prostate cancer on TALAPRO-2, where an overall survival benefit was reported in 2024-25; the prostate dose is 0.5 mg daily. Pfizer markets it. Anaemia is the dominant toxicity, with fatigue, nausea, neutropenia and thrombocytopenia also reported. TALAPRO-2 enrolled patients regardless of HRR status but the US label was limited to HRR-mutant disease, so use in unselected prostate cancer remains contested. For a newcomer: the most potent PARP trapper, used in BRCA breast cancer and alongside hormone therapy in prostate cancer.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Talzenna
- Modality: Small-molecule PARP inhibitor
- Mechanism: PARP inhibitor with ~100x greater trapping than olaparib.
- Approvals: US 2018: gBRCA HER2- locally advanced/metastatic breast cancer; US 2023: HRR-mutant mCRPC with enzalutamide; EU 2019: Germline BRCA1/2-mutated HER2-negative locally advanced or metastatic breast cancer (EMBRACA); marketing authorisation issued 20 June 2019; UK 2024: HER2-negative locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after an anthracycline or a taxane; NICE TA952 (21 February 2024) recommends within the marketing authorisation with a commercial arrangement
- Dosing: Oral; 1 mg once daily (breast); 0.5 mg once daily with enzalutamide (prostate)

## Notes

- Triple-negative breast cancer: 44 percent of EMBRACA patients had triple-negative disease and randomisation was stratified by it (Talzenna label). Final overall survival did not differ (hazard ratio 0.85, medians 19.3 versus 19.5 months); 32.6 percent of the chemotherapy arm later received a PARP inhibitor. Six UK sites took part.
- NICE TA1130 recommends talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer only when chemotherapy is not clinically indicated and abiraterone with prednisolone is not tolerated or is clinically precluded, with the companies' commercial arrangements. It must be funded in England within 90 days of publication.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Talazoparib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Talazoparib
- NICE TA952: talazoparib for HER2-negative advanced breast cancer with germline BRCA mutations (21 February 2024): https://www.nice.org.uk/guidance/ta952
- Talzenna label (openFDA): EMBRACA study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TALZENNA%22
- NICE TA1130: talazoparib with enzalutamide for untreated hormone-relapsed metastatic prostate cancer: https://www.nice.org.uk/guidance/ta1130

## Connected records

- biomarkers: [Germline BRCA1/2 pathogenic variant (gBRCAm)](https://onco.cc/biomarkers/brca-germline/), [Homologous recombination repair gene mutation in prostate cancer](https://onco.cc/biomarkers/hrr-gene-mutation/), [Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations](https://onco.cc/biomarkers/brca-somatic/)
- cancers: [BRCA or PALB2-mutant pancreatic ductal adenocarcinoma](https://onco.cc/cancers/brca-palb2-pdac/), [BRCA-associated triple-negative breast cancer](https://onco.cc/cancers/brca-associated-tnbc/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [Male breast cancer](https://onco.cc/cancers/male-breast-cancer/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Prostate cancer](https://onco.cc/cancers/prostate/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/), [RAD51 foci assay (functional HRD test)](https://onco.cc/technologies/rad51-foci-assay/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/), [PARP](https://onco.cc/targets/parp/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [Genome-wide loss of heterozygosity (gLOH)](https://onco.cc/terms/genome-wide-loss-of-heterozygosity/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters](https://onco.cc/terms/prostate-hrr-eligibility/)
- trials: [Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing](https://onco.cc/trials/nct05059522/), [EMBRACA](https://onco.cc/trials/embraca/), [Lung-MAP (SWOG S1400 and S1900)](https://onco.cc/trials/lung-map/), [Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START)](https://onco.cc/trials/nct05035745/), [Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC](https://onco.cc/trials/nct04821622/), [Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer](https://onco.cc/trials/nct05725200/), [TALAPRO-2](https://onco.cc/trials/talapro-2/), [TAPUR (Targeted Agent and Profiling Utilization Registry)](https://onco.cc/trials/tapur/)
- key papers: [Germline testing in patients with breast cancer: ASCO-Society of Surgical Oncology guideline](https://onco.cc/key-papers/paper-bedrosian-asco-sso-germline-testing-breast-jco-2024/), [Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer](https://onco.cc/key-papers/paper-couch-tnbc-germline-17-genes-jco-2015/), [Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline](https://onco.cc/key-papers/paper-asco-hereditary-breast-cancer-guideline-jco-2020/)
- roadmaps: [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- ideas: [Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later](https://onco.cc/ideas/idea-prostate-hrr-testing-at-metastatic-diagnosis/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/), [Base excision repair, PARP & alkylation damage](https://onco.cc/pathways/base-excision-repair-parp/), [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/), [DNA damage response & homologous recombination](https://onco.cc/pathways/ddr/), [Double-strand break repair: HR versus end joining](https://onco.cc/pathways/homologous-recombination-repair/), [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/), [Synthetic lethality: paired dependencies](https://onco.cc/pathways/synthetic-lethality-map/)
- pairings: [PARP inhibitor + AR pathway inhibitor (prostate)](https://onco.cc/pairings/parp-plus-arpi/)
- drugs: [BRACAnalysis CDx](https://onco.cc/drugs/bracanalysis-cdx/), [Iniparib](https://onco.cc/drugs/iniparib/)
- people: [Jennifer K. Litton](https://onco.cc/people/jennifer-litton/), [Neeraj Agarwal](https://onco.cc/people/neeraj-agarwal/)
- institutions: [Huntsman Cancer Institute, University of Utah](https://onco.cc/institutions/huntsman/)

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JSON: https://onco.cc/api/v1/entities/talazoparib.json