On October 26, Pfizer announced that the U.S. FDA has expanded approval of TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) to the treatment of men with metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. mAPMN/S is also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The approval makes the oral PARP inhibitor TALZENNA plus the androgen receptor pathway inhibitor XTANDI available in an earlier line, providing an opportunity to delay disease progression at a critical stage. The combination was first approved in the U.S. in 2023 for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
The approval is based on the pivotal Phase 3 TALAPRO-3 study, which showed that TALZENNA plus XTANDI reduced the risk of radiographic progression or death by 52% (HR 0.48; 95% CI 0.36-0.65; p<0.0001), with an estimated 77% of patients remaining progression-free at three years. Consistent benefit was observed across BRCA and non-BRCA HRR mutations.
No new safety signals were identified; the most common adverse events were anemia, fatigue, decreased neutrophil count, and asthenia, with anemia (51%) the most common grade 3 or higher event. The results were presented at the 2026 ASCO Annual Meeting and published in The New England Journal of Medicine.

Source: https://investors.pfizer.com/Investors/news-events/News/news-details/2026/Pfizers-TALZENNA-Plus-XTANDI-FDA-Approved-for-an-Earlier-Metastatic-Prostate-Cancer-Treatment-Setting/default.aspx