Pfizer (PFE) said Thursday that Talzenna plus Xtandi combination improved overall survival in patients with metastatic castration-resistant prostate cancer, with or without homologous recombination repair gene mutations, during a phase 3 trial.
The combination showed "a statistically significant and clinically meaningful improvement in overall survival," compared with placebo plus Xtandi, the company said.
The safety profile of the combination was generally consistent with the known safety profile of each medicine, Pfizer said.
The data have been shared with global health authorities, including the US Food and Drug Administration, to support potential updates of the approved labels for Talzenna, it added.
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