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Pfizer's Talzenna plus Xtandi gets FDA priority review for metastatic prostate cancer
The FDA granted priority review to Pfizer's combination of Talzenna and Xtandi in men with metastatic castration-sensitive prostate cancer whose tumours carry HRR mutations. Priority review shortens the FDA review period to six months from the standard 10 months. The application is supported by the Phase 3 TALAPRO-3 trial, in which the combination reduced the risk of radiographic progression or death by 52% versus placebo plus Xtandi.