Posted by Michael Wonder on 23 Jul 2026
FDA grants priority review for Pfizer’s Talzenna plus Xtandi for the treatment of metastatic prostate cancer
22 July 2026 - Pfizer today announced that the US FDA accepted for priority review a supplemental new drug application for Talzenna (talazoparib), an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor, in men with homologous recombination repair gene-altered metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer.
The FDA has set a PDUFA action date in the last quarter of 2026.
