Urology ·
FDA expands talazoparib plus enzalutamide to earlier HRR-mutated prostate cancer; ctDNA analysis backs liquid testing; prehabilitation aids RARP
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The Food and Drug Administration (FDA) on Oct. 26 expanded approval of talazoparib plus enzalutamide to men with HRR gene-mutated metastatic prostate cancer that is androgen pathway modulation-naive or -sensitive, Pfizer said.
A TALAPRO-2 biomarker analysis compared tissue and circulating tumor DNA testing, and a randomized trial found prehabilitation improved quality of life one month after robotic prostatectomy.
THE DETAILS
- FDA Oct 26, 2026The Food and Drug Administration (FDA) on Oct. 26 expanded approval of talazoparib (Talzenna) plus enzalutamide (Xtandi) to men with homologous recombination repair (HRR) gene-mutated metastatic prostate cancer that is androgen pathway modulation-naive or -sensitive, Pfizer said. In the TALAPRO-3 trial of 599 patients, the combination lowered the risk of radiographic progression or death versus placebo plus enzalutamide (hazard ratio 0.48; 95% CI 0.36 to 0.65; P < .0001), according to Pfizer. Interim overall survival was immature and not significant (hazard ratio 0.77; 95% CI 0.56 to 1.04; P = .09). It was approved in June 2023 for castration-resistant disease.
- Research Oct 28, 2026An exploratory biomarker analysis of the phase 3 TALAPRO-2 trial, published Oct. 28 in The Lancet Oncology, found 84% agreement (421 of 501) in HRR gene alteration status between prospective tumor tissue testing and retrospective circulating tumor DNA (ctDNA) testing among patients evaluable by both. With talazoparib plus enzalutamide, detectable baseline ctDNA was associated with shorter radiographic progression-free survival (median 21.0 months versus not reached; hazard ratio 2.46; 95% CI 1.68 to 3.60). Week 9 conversion from positive to negative ctDNA was prognostic of improved radiographic progression-free survival in both arms. Pfizer funded the trial.Sources: The Lancet Oncology, PubMed
- Research Oct 28, 2026In a single-center randomized trial published Oct. 28 in The Journal of Urology, a four-week multimodal prehabilitation program before robotic-assisted radical prostatectomy raised the EORTC QLQ-C30 global health status score one month after surgery by an adjusted mean of 15 points (95% CI 7 to 22; P < .001) versus usual care, the primary end point. The program combined physical and pelvic floor muscle training, nutritional counseling and psychological support; 95 of 100 randomized men were analyzed. The difference fell to 4.5 points at six months, and physical performance and erectile function did not differ.Sources: The Journal of Urology, PubMed
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