US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

doi:10.1200/JCO.23.02182

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US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology - 20 May 2024

Heiss Brian L, Chang Elaine, Gao Xin, Truong Tien, Brave Michael H, Bloomquist Erik, Shah Ankit, Hamed Salaheldin, Kraft Jeffrey, Chiu Haw-Jyh, Ricks Tiffany K, Tilley Amy, Pierce William F, Tang Liuya, Abukhdeir Abdelrahmman, Kalavar Shyam, Philip Reena, Tang Shenghui, Pazdur Richard, Amiri-Kordestani Laleh, Kluetz Paul G, Suzman Daniel L

Abstract excerpt

PURPOSE: The US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for first-line treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: The approval was based on the HRR gene-mutated (HRRm) population of TALAPRO-2, a randomized, double-blind trial that randomly assigned 1,035 patients with...

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PMID: 38452327
DOI: 10.1200/JCO.23.02182
PMCID: PMC11095902

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PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026. Manifest publication-graph-cohort-2026-09-07.1.

Source receipt: pubmed, retrieved 7 Sept 2026.

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