The Food and Drug Administration has agreed to decide by the end of this year whether men with advanced prostate cancer driven by faulty DNA repair genes should get a targeted pill added to standard hormone therapy from the very start of treatment, rather than waiting until the cancer stops responding.
The agency granted priority review to talazoparib, sold as Talzenna, combined with enzalutamide, sold as Xtandi, for metastatic castration-sensitive prostate cancer with alterations in homologous recombination repair genes. A decision is expected in the fourth quarter of 2026.
