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Talazoparib is a DNA-repair inhibitor for selected inherited-BRCA breast cancers and, with hormone treatment, selected advanced prostate cancers.
The current US Talzenna label covers deleterious or suspected deleterious germline-BRCA-mutated HER2-negative locally advanced or metastatic breast cancer, and HRR-gene-mutated metastatic castration-resistant prostate cancer with enzalutamide. The breast indication does not include somatic-only BRCA or an adjuvant indication. Approved dosing differs by setting: 1 mg daily for breast cancer and 0.5 mg daily with enzalutamide for prostate cancer, with adjustments for toxicity, kidney function and interacting medicines. Myelosuppression, including anaemia, neutropenia and thrombocytopenia, requires monitoring. Broad trial enrolment does not broaden the HRR-selected prostate label.
PARP1/2 inhibitor and DNA trapper. Connects to PARP and BRCA1 / BRCA2 (HRD).
1.Talazoparib traps PARP1 on DNA about 100-fold more potently than olaparib
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
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).
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.
Sources: NICE TA952. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
gBRCA HER2-negative locally advanced/metastatic breast cancer (EMBRACA) source
HRR-mutant mCRPC with enzalutamide (TALAPRO-2) source
| Region | Year | Indication |
|---|---|---|
| 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 · https://www.ema.europa.eu/en/medicines/human/EPAR/talzenna |
| 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 · https://www.nice.org.uk/guidance/ta952 |
| 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.
Read for the class this product belongs to (parp inhibitors) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | pfizeroncologytogether.com |
| United Kingdom | NICE: recommended for gBRCA HER2-negative advanced breast cancer (TA952) and with enzalutamide in HRR-mutant mCRPC (2024) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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For TNBC, which is diagnosed young and is the PARP inhibitor-eligible subtype, the guideline makes germline testing part of the diagnostic workup rather than a referral decision.
Mixed, heavily pretreated cancers and no control arm; cannot compare its ORR directly with olaparib trials or establish postoperative benefit.
Sets the surgical and systemic rules for the one in nine to one in six triple-negative patients who carry a germline BRCA variant (11 to 17 percent by cohort); the adjuvant gap it named was filled by OlympiA the following year.
This cohort underpins the guideline shift to germline BRCA1/2 testing for all TNBC patients regardless of age or family history, and it is the prevalence figure the corpus uses for germline BRCA1 in TNBC.
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.
Shares PARP inhibitor + AR pathway inhibitor (prostate), Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, RAD51 foci assay (functional HRD test), Genome-wide loss of heterozygosity (gLOH).
Shares Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, RAD51 foci assay (functional HRD test), Genome-wide loss of heterozygosity (gLOH), Base excision repair, PARP & alkylation damage.
Shares Genome-wide loss of heterozygosity (gLOH), Base excision repair, PARP & alkylation damage, Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations, Test every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later.
Shares PARP inhibitor + AR pathway inhibitor (prostate), Iniparib, Germline testing in patients with breast cancer: ASCO-Society of Surgical Oncology guideline, Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer.
Shares Base excision repair, PARP & alkylation damage, Tumour (somatic or germline) BRCA1/2 mutation and HRR gene alterations, Homologous recombination repair gene mutation in prostate cancer, Synthetic lethality: paired dependencies.
Shares Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters, RAD51 foci assay (functional HRD test), Genome-wide loss of heterozygosity (gLOH), Base excision repair, PARP & alkylation damage.
Shares Germline testing in patients with breast cancer: ASCO-Society of Surgical Oncology guideline, Inherited mutations in 17 breast cancer susceptibility genes among a large triple-negative breast cancer cohort unselected for family history of breast cancer, BRACAnalysis CDx, EMBRACA.
Shares Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline, BRCA-associated triple-negative breast cancer, HR-positive metastatic breast cancer after CDK4/6 inhibitors, PARP inhibitors.
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