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drugsProductApproved2018🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Talazoparib

Talazoparib is the most potent PARP trapper, approved in BRCA breast cancer and with enzalutamide in prostate cancer.

EMBRACA (gBRCA HER2- metastatic breast), TALAPRO-2 (with enzalutamide in mCRPC; HRR-mutant label 2023, OS benefit 2024-25). Pfizer.

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Talazoparib
PubChem
Mechanism, step by step
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1.Talazoparib traps PARP1 on DNA about 100-fold more potently than olaparib

Modality
Small-molecule PARP inhibitor
Mechanism
PARP inhibitor with ~100x greater trapping than olaparib.
Brand / code
Talzenna
Dosing & schedule
Route
Oral
Schedule
1 mg once daily (breast); 0.5 mg once daily with enzalutamide (prostate)
Dose modifications
0.75 mg for moderate renal impairment; hold for grade ≥3 cytopenias
Monitoring
Blood counts monthly

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Germline BRCA (breast) or HRR gene alteration (prostate, with enzalutamide).

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2019 for germline BRCA HER2-negative breast cancer; NICE recommended it in 2024-25 with a commercial arrangement. TA number not verified. mCRPC with enzalutamide appraised separately.

Sources: NICE search: talazoparib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 16 Oct 2018ApprovalUS

    gBRCA HER2-negative locally advanced/metastatic breast cancer (EMBRACA) source

  2. 20 Jun 2023ApprovalUS

    HRR-mutant mCRPC with enzalutamide (TALAPRO-2) source

Approvals

RegionYearIndication
US2018gBRCA HER2- locally advanced/metastatic breast cancer
US2023HRR-mutant mCRPC with enzalutamide

Safety

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Toxicity profile
Adverse event
Anaemia
Fatigue
Nausea
Neutropenia
Thrombocytopenia
Headache
Alopecia

EMBRACA: 53% any grade, 39% grade 3-4. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part D (oral); commercial plans per formulary, often with prior authorisation
United KingdomNICE: recommended for gBRCA HER2-negative advanced breast cancer (TA952) and with enzalutamide in HRR-mutant mCRPC (2024)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
73 studies20 recruiting67 Phase 26 Phase 3
Search “Talazoparib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Talazoparib
intervention: Talazoparib
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend97 papers in the last 12 months+9% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Talazoparib" OR ABSTRACT:"Talazoparib" OR TITLE:"Talzenna" OR ABSTRACT:"Talzenna") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Talazoparib, not a curated reading list.

Connected

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