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FDA grants priority review to talazoparib plus enzalutamide for HRR gene-altered mCSPC
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Fusion42 · 23 July 2026 · Fusion42 review
The FDA granted priority review to Pfizer's talazoparib plus enzalutamide for metastatic castration-sensitive prostate cancer with HRR gene alterations, with PDUFA target action in Q4 2026. The phase 3 TALAPRO-3 trial showed a 52% reduction in radiographic progression or death versus enzalutamide alone, with stronger efficacy in BRCA-mutated patients (63% risk reduction).
This Wire brief sits within Fusion42's coverage of Digital Health.
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If you're building HRR gene testing for prostate cancer, this approval creates immediate clinical urgency - every mCSPC patient now needs testing to qualify for a drug with proven 52% progression benefit. The precision medicine layer just became standard-of-care, not optional.
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1 source · 23 Jul 2026
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